Clinical Research Engineer
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should not repeat job title. We need to include sections only when posting has real specific content. We have content for About OrganOx (company description) maybe treat as "About the role"? Actually "About OrganOx" is about company, not role. Could map to "About the role"? But they said use headings like About the role, Responsibilities, etc. We can still use About the role heading and put company description there? Might be okay. However they said do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings. So we can have About the role (company overview). Then Responsibilities (list). Then Requirements (maybe combine Skills & Experience). Then Qualifications. Then Benefits. No Pay or Schedule given. So omit those.
We need to use - for any list of duties/requirements/benefits, and
for prose.
We need to preserve all substantive information, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO etc. There's none. Also remove duplicated lines. There's some duplication: "Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures" appears multiple times. We need to preserve but not duplicate? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." It doesn't explicitly say to deduplicate, but we should avoid duplicated lines? It says "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." So we should remove duplicated lines. So we need to deduplicate repeated sentences.
Let's extract content.
About OrganOx paragraph: "OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions."
Position Summary: "The Clinical Research Engineer is responsible for: Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures Serving as the subject matter expert on the device and procedures during IDE studies and research projects Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies"
Major Responsibilities: Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for: (note typo Enginer). Then bullet-like sentences:
- Product Knowledge and Training
Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures
Support the development of training and other support materials for FDA approved and investigational/research devices and procedures
Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures
Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center
Interface with Development and Engineering in order to obtain answers to technical questions
Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering
- Clinical Studies
Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols
Support the development of clinical study protocols
Support sound and thorough data collection ensure data analysis in accordance with the protocol (maybe missing punctuation)
Develop training and other support materials for clinical protocols, study procedures, data collection and review
Assist in the development and implementation of a study-specific database for clinical studies
Assist Clinical Research Associates with review of study data
Support writing and review of clinical study reports and the clinical portion of FDA submissions
Identify and report study protocol challenges and compliance issues to clinical management
- Management support
Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites
Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures
Other duties as assigned by VP, Clinical Affairs & Training
Requirements Skills & Experience: list:
- Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different therapeutic areas
- Experience in a clinical setting and clinical studies is beneficial
- Knowledge of project management tools and practices
- Proven ability to work in a matrix organization
- Ability to work independently and as a part of a team
- Have an analytic approach to problem solving
- Excellent presentation and computer skills
- Strong communicator, capable of effectively presenting ideas and concepts
- Excellent organizational skills and attention to detail
Qualifications:
- Certified Clinical Perfusionist degree strongly preferred
- Other possible degrees: Bachelor's degree in other health profession, science, or engineering field with a strong technical and clinical background.
- Masters degree preferred
- Experience with perfusion devices and management of patients or donor organs is a must
- Previous experience in the medical device industry with preference for transplant and perfusion devices is desired
- Computer literate and familiar with Word, Excel, and PowerPoint
- Be able to travel regularly within North America as required
- Right to work in the USA
- Have a full driver's license
Benefits paragraph: "We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development."
We need to format as HTML with
headings and - for lists,
for prose.
We need to decide which sections to include: About the role (company overview), Responsibilities (list), Requirements (maybe combine Skills & Experience), Qualifications, Benefits.
We should not include Pay or Schedule.
We need to ensure we don't include placeholder text like "commensurate with experience". Not present.
We need to remove duplicated lines: The phrase "Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures" appears multiple times: in Position Summary, under Product Knowledge and Training, maybe elsewhere. We should keep only one instance? The instruction says remove duplicated lines. So we should deduplicate that sentence across the whole output. However we need to preserve all substantive information; removing a duplicate line is okay as it's duplicate. So we should keep only one occurrence.
Similarly other duplicates? Let's check.
"Support the development of training and other support materials for FDA approved and investigational/research devices and procedures" appears maybe only once.
"Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures" appears once.
"Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center" once.
"Interface with Development and Engineering in order to obtain answers to technical questions" once.
"Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering" once.
"Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols" appears maybe once.
"Support the development of clinical study protocols" appears maybe twice? Actually under Clinical Studies bullet list: "Support the development of clinical study protocols" appears once. Also earlier maybe not.
"Support sound and thorough data collection ensure data analysis in accordance with the protocol" maybe once.
"Develop training and other support materials for clinical protocols, study procedures, data collection and review" once.
"Assist in the development and implementation of a study-specific database for clinical studies" once.
"Assist Clinical Research Associates with review of study data" once.
"Support writing and review of clinical study reports and the clinical portion of FDA submissions" once.
"Identify and report study protocol challenges and compliance issues to clinical management" once.
"Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites" once.
"Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures" once.
"Other duties as assigned by VP, Clinical Affairs & Training" once.
Now Requirements list: none duplicates.
Qualifications list: none duplicates.
Now we need to format.
We'll produce:
About the role
OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Responsibilities
- Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures
- Support the development of training and other support materials for FDA approved and investigational/research devices and procedures
- Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures
- Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center
- Interface with Development and Engineering in order to obtain answers to technical questions
- Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering
- Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols
- Support the development of clinical study protocols
- Support sound and thorough data collection and ensure data analysis in accordance with the protocol
- Develop training and other support materials for clinical protocols, study procedures, data collection and review
- Assist in the development and implementation of a study-specific database for clinical studies
- Assist Clinical Research Associates with review of study data
- Support writing and review of clinical study reports and the clinical portion of FDA submissions
- Identify and report study protocol challenges
for prose. We need to preserve all substantive information, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO etc. There's none. Also remove duplicated lines. There's some duplication: "Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures" appears multiple times. We need to preserve but not duplicate? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." It doesn't explicitly say to deduplicate, but we should avoid duplicated lines? It says "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." So we should remove duplicated lines. So we need to deduplicate repeated sentences. Let's extract content. About OrganOx paragraph: "OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions." Position Summary: "The Clinical Research Engineer is responsible for: Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures Serving as the subject matter expert on the device and procedures during IDE studies and research projects Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies" Major Responsibilities: Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for: (note typo Enginer). Then bullet-like sentences: - Product Knowledge and Training Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures Support the development of training and other support materials for FDA approved and investigational/research devices and procedures Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center Interface with Development and Engineering in order to obtain answers to technical questions Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering - Clinical Studies Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols Support the development of clinical study protocols Support sound and thorough data collection ensure data analysis in accordance with the protocol (maybe missing punctuation) Develop training and other support materials for clinical protocols, study procedures, data collection and review Assist in the development and implementation of a study-specific database for clinical studies Assist Clinical Research Associates with review of study data Support writing and review of clinical study reports and the clinical portion of FDA submissions Identify and report study protocol challenges and compliance issues to clinical management - Management support Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures Other duties as assigned by VP, Clinical Affairs & Training Requirements Skills & Experience: list: - Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different therapeutic areas - Experience in a clinical setting and clinical studies is beneficial - Knowledge of project management tools and practices - Proven ability to work in a matrix organization - Ability to work independently and as a part of a team - Have an analytic approach to problem solving - Excellent presentation and computer skills - Strong communicator, capable of effectively presenting ideas and concepts - Excellent organizational skills and attention to detail Qualifications: - Certified Clinical Perfusionist degree strongly preferred - Other possible degrees: Bachelor's degree in other health profession, science, or engineering field with a strong technical and clinical background. - Masters degree preferred - Experience with perfusion devices and management of patients or donor organs is a must - Previous experience in the medical device industry with preference for transplant and perfusion devices is desired - Computer literate and familiar with Word, Excel, and PowerPoint - Be able to travel regularly within North America as required - Right to work in the USA - Have a full driver's license Benefits paragraph: "We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development." We need to format as HTML with
headings and - for lists,
for prose.
We need to decide which sections to include: About the role (company overview), Responsibilities (list), Requirements (maybe combine Skills & Experience), Qualifications, Benefits.
We should not include Pay or Schedule.
We need to ensure we don't include placeholder text like "commensurate with experience". Not present.
We need to remove duplicated lines: The phrase "Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures" appears multiple times: in Position Summary, under Product Knowledge and Training, maybe elsewhere. We should keep only one instance? The instruction says remove duplicated lines. So we should deduplicate that sentence across the whole output. However we need to preserve all substantive information; removing a duplicate line is okay as it's duplicate. So we should keep only one occurrence.
Similarly other duplicates? Let's check.
"Support the development of training and other support materials for FDA approved and investigational/research devices and procedures" appears maybe only once.
"Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures" appears once.
"Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center" once.
"Interface with Development and Engineering in order to obtain answers to technical questions" once.
"Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering" once.
"Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols" appears maybe once.
"Support the development of clinical study protocols" appears maybe twice? Actually under Clinical Studies bullet list: "Support the development of clinical study protocols" appears once. Also earlier maybe not.
"Support sound and thorough data collection ensure data analysis in accordance with the protocol" maybe once.
"Develop training and other support materials for clinical protocols, study procedures, data collection and review" once.
"Assist in the development and implementation of a study-specific database for clinical studies" once.
"Assist Clinical Research Associates with review of study data" once.
"Support writing and review of clinical study reports and the clinical portion of FDA submissions" once.
"Identify and report study protocol challenges and compliance issues to clinical management" once.
"Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites" once.
"Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures" once.
"Other duties as assigned by VP, Clinical Affairs & Training" once.
Now Requirements list: none duplicates.
Qualifications list: none duplicates.
Now we need to format.
We'll produce:
About the role
OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Responsibilities
- Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures
- Support the development of training and other support materials for FDA approved and investigational/research devices and procedures
- Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures
- Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center
- Interface with Development and Engineering in order to obtain answers to technical questions
- Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering
- Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols
- Support the development of clinical study protocols
- Support sound and thorough data collection and ensure data analysis in accordance with the protocol
- Develop training and other support materials for clinical protocols, study procedures, data collection and review
- Assist in the development and implementation of a study-specific database for clinical studies
- Assist Clinical Research Associates with review of study data
- Support writing and review of clinical study reports and the clinical portion of FDA submissions
- Identify and report study protocol challenges
for prose. We need to decide which sections to include: About the role (company overview), Responsibilities (list), Requirements (maybe combine Skills & Experience), Qualifications, Benefits. We should not include Pay or Schedule. We need to ensure we don't include placeholder text like "commensurate with experience". Not present. We need to remove duplicated lines: The phrase "Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures" appears multiple times: in Position Summary, under Product Knowledge and Training, maybe elsewhere. We should keep only one instance? The instruction says remove duplicated lines. So we should deduplicate that sentence across the whole output. However we need to preserve all substantive information; removing a duplicate line is okay as it's duplicate. So we should keep only one occurrence. Similarly other duplicates? Let's check. "Support the development of training and other support materials for FDA approved and investigational/research devices and procedures" appears maybe only once. "Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures" appears once. "Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center" once. "Interface with Development and Engineering in order to obtain answers to technical questions" once. "Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering" once. "Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols" appears maybe once. "Support the development of clinical study protocols" appears maybe twice? Actually under Clinical Studies bullet list: "Support the development of clinical study protocols" appears once. Also earlier maybe not. "Support sound and thorough data collection ensure data analysis in accordance with the protocol" maybe once. "Develop training and other support materials for clinical protocols, study procedures, data collection and review" once. "Assist in the development and implementation of a study-specific database for clinical studies" once. "Assist Clinical Research Associates with review of study data" once. "Support writing and review of clinical study reports and the clinical portion of FDA submissions" once. "Identify and report study protocol challenges and compliance issues to clinical management" once. "Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites" once. "Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures" once. "Other duties as assigned by VP, Clinical Affairs & Training" once. Now Requirements list: none duplicates. Qualifications list: none duplicates. Now we need to format. We'll produce:
About the role
OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Responsibilities
- Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures
- Support the development of training and other support materials for FDA approved and investigational/research devices and procedures
- Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures
- Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center
- Interface with Development and Engineering in order to obtain answers to technical questions
- Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering
- Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols
- Support the development of clinical study protocols
- Support sound and thorough data collection and ensure data analysis in accordance with the protocol
- Develop training and other support materials for clinical protocols, study procedures, data collection and review
- Assist in the development and implementation of a study-specific database for clinical studies
- Assist Clinical Research Associates with review of study data
- Support writing and review of clinical study reports and the clinical portion of FDA submissions
- Identify and report study protocol challenges