Site Endpoint Evaluation Visit (SEEV) Specialist I
About The Position
We are looking for a SEEV Specialist I to join our team! Do you have clinical research background? Are you open to travel of up to 80% of the time? Do you adapt to change easily? Can you quickly connect and build strong relationships with others? Can you proactively identify a problem and develop solutions? If you have answered yes to these questions, then keep reading! Remote candidates are welcome to apply. In this position you will: Review and provide feedback on EQuIP® study-specific documents (e.g., Study Manual, CRFs, Source Document, SEEV Plan, SEEV Report Templates). Contact study site and schedule Site Endpoint Evaluation Visits (SEEV) as assigned. Provide sites with confirmation documentation regarding the SEEV. Conduct SEEVs domestically and internationally including hands-on training with site staff on endpoint data collection, source document/reference tools review for endpoint data and equipment assessment according to the CPC SOP. Understand and comply with all CPC Polices, SOPs and WIs related to assigned activities. Provide detailed, accurate and comprehensive written reports of the SEEVs within the allowable timeframe. Report any study site concerns to the study Project Manager within a timely manner. Conduct online CRA/Sponsor endpoint trainings. Process Core Lab submissions; including tracking, distribution of materials to appropriate CPC staff members, filing and uploading documents to the TMF. Distribute feedback to sites on quality issues, as required by project. Follow up with appropriate individuals (site staff or site CRA) to ensure complete and documented resolution of issues. Contact appropriate individuals (site staff or site CRA) regarding incomplete, inaccurate or missing submissions and other documents as required by project. Maintain study recruitment logs, reconcile against Core Lab submissions and follow up with site staff on any missing submissions. Participate as a member of designated project teams to support Core Lab staff. Establish and maintain central project and regulatory files, both electronic and paper. Assist in scheduling and writing meeting minutes for project team meetings. Help assess project issues and propose resolutions to the PM. Communicate with sites as necessary. Help ensure the overall quality of project services and deliverables. Assist in scheduling SEEVs for other team members, as requested. Perform additional activities as assigned. Here’s what you will need to bring to the table: Nursing or bachelor’s degree preferred but not required. A minimum of 2 years of experience in a clinical research setting or 1 year of experience at CPC as Research Assistant is required. Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical trials. Proficiency in Microsoft Office, particularly Outlook, Word and Excel. Excellent interpersonal communication skills, organizational and problem-solving skills. Great attention to detail. Ability to work as a member of a team and to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner. Ability to manage conflicts. Willingness to travel up to 80%, including internationally. Must reside near an international airport. Note: Viable applicants will be required to pass a background and education verification check.
Requirements
- A minimum of 2 years of experience in a clinical research setting or 1 year of experience at CPC as Research Assistant is required.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
- Proficiency in Microsoft Office, particularly Outlook, Word and Excel.
- Excellent interpersonal communication skills, organizational and problem-solving skills.
- Great attention to detail.
- Ability to work as a member of a team and to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.
- Ability to manage conflicts.
- Willingness to travel up to 80%, including internationally.
- Must reside near an international airport.
Nice To Haves
- Nursing or bachelor’s degree preferred but not required.
Responsibilities
- Review and provide feedback on EQuIP® study-specific documents (e.g., Study Manual, CRFs, Source Document, SEEV Plan, SEEV Report Templates).
- Contact study site and schedule Site Endpoint Evaluation Visits (SEEV) as assigned. Provide sites with confirmation documentation regarding the SEEV.
- Conduct SEEVs domestically and internationally including hands-on training with site staff on endpoint data collection, source document/reference tools review for endpoint data and equipment assessment according to the CPC SOP.
- Understand and comply with all CPC Polices, SOPs and WIs related to assigned activities.
- Provide detailed, accurate and comprehensive written reports of the SEEVs within the allowable timeframe.
- Report any study site concerns to the study Project Manager within a timely manner.
- Conduct online CRA/Sponsor endpoint trainings.
- Process Core Lab submissions; including tracking, distribution of materials to appropriate CPC staff members, filing and uploading documents to the TMF.
- Distribute feedback to sites on quality issues, as required by project. Follow up with appropriate individuals (site staff or site CRA) to ensure complete and documented resolution of issues.
- Contact appropriate individuals (site staff or site CRA) regarding incomplete, inaccurate or missing submissions and other documents as required by project.
- Maintain study recruitment logs, reconcile against Core Lab submissions and follow up with site staff on any missing submissions.
- Participate as a member of designated project teams to support Core Lab staff. Establish and maintain central project and regulatory files, both electronic and paper.
- Assist in scheduling and writing meeting minutes for project team meetings.
- Help assess project issues and propose resolutions to the PM.
- Communicate with sites as necessary.
- Help ensure the overall quality of project services and deliverables.
- Assist in scheduling SEEVs for other team members, as requested.
- Perform additional activities as assigned.
Benefits
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 11 paid holidays
- 15 - 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
101-250 employees
