Experienced Clinical Research Associate (CRA II / SR CRA) - US West- Multiple Therapeutic Areas Available
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have content: description includes about role, responsibilities, education/experience requirements, knowledge/skills/abilities, working conditions, compensation and benefits, schedule (Work Schedule Standard (Mon-Fri) Environmental Conditions Office). Also mention travel up to 75% etc.
We must not repeat job title as heading. No Job ID etc. Remove boilerplate.
We need to preserve all substantive info. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to decide which sections to include: About the role (intro paragraph), Responsibilities (list of duties), Requirements (education/experience), Qualifications maybe overlapping? Could combine but we need to follow instruction: Use headings only when posting has real specific content. We have content for About the role, Responsibilities, Requirements (education/experience), Knowledge/Skills/Abilities (Skills), Benefits, Pay, Schedule. Also Working Conditions maybe could be part of About? But we could include as a separate section maybe "Working Conditions" but not in allowed headings list. The allowed headings list includes only those; we should not create other headings. So we must fit Working Conditions into one of those sections, maybe under About the role or Responsibilities. Probably under About the role.
We must not create sections with filler like "commensurate with experience". We have actual content.
We need to output only HTML fragment.
Let's extract content.
About the role: "Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. This role is for experienced, independent monitors with experience completing onsite visits regionally across the US. Up to 75% travel is a requirement."
We can put that in
.
Responsibilities: list of duties from "What You’ll Do:" bullet points. We'll create
- each duty.
List items:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution.
- Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
- Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
That's many items; okay.
Requirements (Education and Experience Requirements): list.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
We can put as
.
Skills (Knowledge, Skills and Abilities): list.
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
We can put as .
Benefits: from "Compensation And Benefits" section: we have salary range and benefits list.
We need separate Pay and Benefits sections? The instruction: Use headings for Benefits, Pay, Schedule. So we need Pay section for salary range, Benefits section for benefits list, Schedule section for work schedule.
Pay: "The salary range estimated for this position based in California is $84,000.00–$120,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy."
We can put that in under
Pay
.
Benefits: list of benefits:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
We can put as .
Schedule: "Work Schedule Standard (Mon-Fri) Environmental Conditions Office". Also mention travel up to 75% etc. But schedule heading should contain schedule info. We have "Work Schedule Standard (Mon-Fri)". Also mention travel requirements maybe not schedule but could be included. We'll put schedule: standard Mon-Fri, office environment, up to 75% travel required.
We can put as .
We also have Working Conditions and Environment details; we could incorporate into About the role or maybe into Schedule? But schedule heading is for schedule only. We could add a paragraph about working conditions under About the role after intro. That's fine.
We must not repeat job title as heading. Already not.
We must not include boilerplate like EEO etc. Already removed.
Now produce HTML fragment:
About the role
...
Responsibilities
...
Requirements
...
Skills
...
Pay
...
Benefits
...
Schedule
...
Make sure to preserve all info. Ensure no extra spaces.
Let's craft the About the role paragraph: combine the intro paragraphs.
About the role paragraph:
"Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. This role is for experienced, independent monitors with experience completing onsite visits regionally across the US. Up to 75% travel is a requirement."
We could also add working conditions after that but maybe not needed.
Now Responsibilities list: each - with the duty sentences.
We need to ensure we don't lose any nuance.
Let's list them exactly as given.
I'll copy each bullet.
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team
for prose. We need to decide which sections to include: About the role (intro paragraph), Responsibilities (list of duties), Requirements (education/experience), Qualifications maybe overlapping? Could combine but we need to follow instruction: Use headings only when posting has real specific content. We have content for About the role, Responsibilities, Requirements (education/experience), Knowledge/Skills/Abilities (Skills), Benefits, Pay, Schedule. Also Working Conditions maybe could be part of About? But we could include as a separate section maybe "Working Conditions" but not in allowed headings list. The allowed headings list includes only those; we should not create other headings. So we must fit Working Conditions into one of those sections, maybe under About the role or Responsibilities. Probably under About the role. We must not create sections with filler like "commensurate with experience". We have actual content. We need to output only HTML fragment. Let's extract content. About the role: "Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. This role is for experienced, independent monitors with experience completing onsite visits regionally across the US. Up to 75% travel is a requirement." We can put that in
. Responsibilities: list of duties from "What You’ll Do:" bullet points. We'll create
- each duty.
List items:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution.
- Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
- Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
That's many items; okay.
Requirements (Education and Experience Requirements): list.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
We can put as
- .
Skills (Knowledge, Skills and Abilities): list.
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
We can put as
- with the duty sentences. We need to ensure we don't lose any nuance. Let's list them exactly as given. I'll copy each bullet. - Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. - Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. - Assess investigational product through physical inventory and records review. - Documents observations in reports and letters in a timely manner using approved business writing standards. - Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. - May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. - Conducts monitoring tasks in accordance with the approved monitoring plan. - Participates in the investigator payment process. - Ensures a shared responsibility with other project team
- .
Benefits: from "Compensation And Benefits" section: we have salary range and benefits list.
We need separate Pay and Benefits sections? The instruction: Use headings for Benefits, Pay, Schedule. So we need Pay section for salary range, Benefits section for benefits list, Schedule section for work schedule.
Pay: "The salary range estimated for this position based in California is $84,000.00–$120,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy."
We can put that in
under
Pay
. Benefits: list of benefits: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount - For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards We can put as- .
Schedule: "Work Schedule Standard (Mon-Fri) Environmental Conditions Office". Also mention travel up to 75% etc. But schedule heading should contain schedule info. We have "Work Schedule Standard (Mon-Fri)". Also mention travel requirements maybe not schedule but could be included. We'll put schedule: standard Mon-Fri, office environment, up to 75% travel required.
We can put as
. We also have Working Conditions and Environment details; we could incorporate into About the role or maybe into Schedule? But schedule heading is for schedule only. We could add a paragraph about working conditions under About the role after intro. That's fine. We must not repeat job title as heading. Already not. We must not include boilerplate like EEO etc. Already removed. Now produce HTML fragment:
About the role
...
Responsibilities
- ...
Requirements
- ...
Skills
- ...
Pay
...
Benefits
- ...
Schedule
...
Make sure to preserve all info. Ensure no extra spaces. Let's craft the About the role paragraph: combine the intro paragraphs. About the role paragraph: "Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. This role is for experienced, independent monitors with experience completing onsite visits regionally across the US. Up to 75% travel is a requirement." We could also add working conditions after that but maybe not needed. Now Responsibilities list: each