Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated
Syneos Health · United States · 1 mo ago
RemoteRemoteAnalystFull-time
We need to output HTML fragment with sections using for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate, duplicated lines, application instructions, cookie/navigation/legal/EEO etc. Must not include sections with filler like "commensurate with experience". Must not create Pay/Schedule/Benefits unless posting actually states them. Let's see if posting includes Pay, Benefits, Schedule. It mentions "Ability to manage required travel of up to 75% on a regular basis" and later "Site travel of approximately 50-75% is required". That's travel, not schedule. No explicit pay, benefits, schedule. So we should not include Pay, Benefits, Schedule sections.
We need sections: About the role, Responsibilities, Requirements, Qualifications, Skills maybe. Let's parse content.
The posting includes description: "Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated Syneos Health® is a leading fully-integrated life sciences services organization..." That's about the company. Could be "About the role" or "About Syneos Health". The instruction: use
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate, duplicated lines, application instructions, cookie/navigation/legal/EEO etc. Must not include sections with filler like "commensurate with experience". Must not create Pay/Schedule/Benefits unless posting actually states them. Let's see if posting includes Pay, Benefits, Schedule. It mentions "Ability to manage required travel of up to 75% on a regular basis" and later "Site travel of approximately 50-75% is required". That's travel, not schedule. No explicit pay, benefits, schedule. So we should not include Pay, Benefits, Schedule sections.
We need sections: About the role, Responsibilities, Requirements, Qualifications, Skills maybe. Let's parse content.
The posting includes description: "Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated Syneos Health® is a leading fully-integrated life sciences services organization..." That's about the company. Could be "About the role" or "About Syneos Health". The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role (maybe summarizing role). We'll include a paragraph about the role: Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated... plus description of Syneos Health.
Responsibilities: The long list under "Job Responsibilities MUST HAVE: early-phase oncology experience..." and then many bullet-like sentences. We need to convert to - . Must preserve all substantive info. We'll extract each responsibility as list items.
Requirements: There's a "Qualifications:" section later, plus "Qualifications/Requirements" near end. We need to separate Requirements vs Qualifications? The instruction says we can have Requirements and Qualifications sections. We need to decide what goes where. Typically Requirements are mandatory experience/skills; Qualifications are education etc. We'll parse.
From text:
"Qualifications: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills.
Moderate level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis"
Later: "Qualifications/Requirements Typically requires a minimum of 6+ years of experience with a Bachelor's Degree, or 4+ years of experience with a post graduate degree.
Significant experience monitoring Oncology (solid tumor) trials with proven experience monitoring phase I Oncology is required.
Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required.
Experience utilizing Veeva CTMS, CDMS, RTSM and TMF (a minimum of 2 years) is required.
Experience supporting site and/or sponsor inspections is required.
Experience auditing sites and TMF is preferred.
Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs or decrease in cases when remote monitoring and Oversight Visits occur."
Also earlier: "Job Responsibilities MUST HAVE: early-phase oncology experience. Experience with first-in-human, dose-limiting toxicity, or dose-escalation studies, which is a core requirement for this project. Direct CRA supervisory oversight."
Thus we can combine requirements: early-phase oncology experience, first-in-human etc, direct CRA supervisory oversight, etc. Also from Qualifications/Requirements: 6+ years experience with BS or 4+ years with postgrad, significant oncology solid tumor, phase I experience, independent on-site/remote monitoring, Veeva experience 2 years, site/sponsor inspections, auditing sites TMF preferred, travel 50-75%.
We'll create a Requirements section with those bullet points.
Skills: maybe from "Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected. Good computer skills, embrace new technologies." Also maybe "Ability to manage required travel". We'll put those under Skills.
About the role: include description of role and company.
We must not include boilerplate like "Over the past 5 years, we have worked with 94%..." that's maybe about company but could be considered About the role? It's still substantive about Syneos Health. We can include it in About the role.
We must not include duplicated lines. Ensure we don't repeat same info.
Let's extract unique points.
First, About the role paragraph: combine the initial description: "Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress."
That's a lot but we can keep as paragraph(s). Might be okay.
Responsibilities: list each duty.
Let's extract responsibilities from the long block:
- Early-phase oncology experience (must have)
- Experience with first-in-human, dose-limiting toxicity, or dose-escalation studies (core requirement)
- Direct CRA supervisory oversight
- Hands-on monitoring oversight visit, trip report review, or multi-country CRA supervision
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes.
- Conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verifies site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Verifies issues or risks associated with blinded or randomized information related to IP.
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Reconciles contents of the ISF with the Trial Master File (TMF).
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Supports subject/patient recruitment, retention and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt to changing priorities to achieve goals / targets.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide direct supervision, training and/or mentorship to more junior level CRAs.
- Performs training and sign off visits for junior CRA staff, as assigned.
- May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.
- This could include participation in business development proposals and/or defense meetings.
- For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II.
- Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
- The SMA II may be requested to train junior staff
- Identify and communicate out of scope activities to Lead CRA/Project Manager
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.
- Identify operational efficiencies and process improvements
- Develop study and country level informed consent forms
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
- Participate in bid defense meetings
- Provide input into Requests for Proposals (RFPs), scope and budgeting.
- Develop site management strategy.
- Participate in Case Report Form design and edit check development.
That's a lot but we need to preserve all substantive info. We'll output as
- items.
Requirements: list:
- Early-phase oncology experience (must have)
- Experience with first-in-human, dose-limiting
- . Must preserve all substantive info. We'll extract each responsibility as list items.
Requirements: There's a "Qualifications:" section later, plus "Qualifications/Requirements" near end. We need to separate Requirements vs Qualifications? The instruction says we can have Requirements and Qualifications sections. We need to decide what goes where. Typically Requirements are mandatory experience/skills; Qualifications are education etc. We'll parse.
From text:
"Qualifications: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills.
Moderate level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis"
Later: "Qualifications/Requirements Typically requires a minimum of 6+ years of experience with a Bachelor's Degree, or 4+ years of experience with a post graduate degree.
Significant experience monitoring Oncology (solid tumor) trials with proven experience monitoring phase I Oncology is required.
Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required.
Experience utilizing Veeva CTMS, CDMS, RTSM and TMF (a minimum of 2 years) is required.
Experience supporting site and/or sponsor inspections is required.
Experience auditing sites and TMF is preferred.
Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs or decrease in cases when remote monitoring and Oversight Visits occur."
Also earlier: "Job Responsibilities MUST HAVE: early-phase oncology experience. Experience with first-in-human, dose-limiting toxicity, or dose-escalation studies, which is a core requirement for this project. Direct CRA supervisory oversight."
Thus we can combine requirements: early-phase oncology experience, first-in-human etc, direct CRA supervisory oversight, etc. Also from Qualifications/Requirements: 6+ years experience with BS or 4+ years with postgrad, significant oncology solid tumor, phase I experience, independent on-site/remote monitoring, Veeva experience 2 years, site/sponsor inspections, auditing sites TMF preferred, travel 50-75%.
We'll create a Requirements section with those bullet points.
Skills: maybe from "Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected. Good computer skills, embrace new technologies." Also maybe "Ability to manage required travel". We'll put those under Skills.
About the role: include description of role and company.
We must not include boilerplate like "Over the past 5 years, we have worked with 94%..." that's maybe about company but could be considered About the role? It's still substantive about Syneos Health. We can include it in About the role.
We must not include duplicated lines. Ensure we don't repeat same info.
Let's extract unique points.
First, About the role paragraph: combine the initial description: "Sr CRA II / Lead CRA (phase 1 Oncology a must) Sponsor dedicated Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress."
That's a lot but we can keep as paragraph(s). Might be okay.
Responsibilities: list each duty.
Let's extract responsibilities from the long block:
- Early-phase oncology experience (must have)
- Experience with first-in-human, dose-limiting toxicity, or dose-escalation studies (core requirement)
- Direct CRA supervisory oversight
- Hands-on monitoring oversight visit, trip report review, or multi-country CRA supervision
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes.
- Conducts Source Document Review of appropriate site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verifies site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Verifies issues or risks associated with blinded or randomized information related to IP.
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Reconciles contents of the ISF with the Trial Master File (TMF).
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Supports subject/patient recruitment, retention and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt to changing priorities to achieve goals / targets.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide direct supervision, training and/or mentorship to more junior level CRAs.
- Performs training and sign off visits for junior CRA staff, as assigned.
- May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.
- This could include participation in business development proposals and/or defense meetings.
- For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II.
- Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
- The SMA II may be requested to train junior staff
- Identify and communicate out of scope activities to Lead CRA/Project Manager
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.
- Identify operational efficiencies and process improvements
- Develop study and country level informed consent forms
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
- Participate in bid defense meetings
- Provide input into Requests for Proposals (RFPs), scope and budgeting.
- Develop site management strategy.
- Participate in Case Report Form design and edit check development.
That's a lot but we need to preserve all substantive info. We'll output as
- items. Requirements: list: - Early-phase oncology experience (must have) - Experience with first-in-human, dose-limiting