Contact study sites and schedule SEEVs as assigned.
Coordinate travel arrangements for domestic and international SEEVs.
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.
Complete detailed, accurate, and timely SEEV reports and communicate findings to internal study teams.
Escalate site concerns identified during SEEVs to the appropriate Clinical Trial Manager or Project Manager.
Assist Clinical Trial Managers and CRAs with enrollment and retention escalations for international sites.
Support tracking of study recruitment and enrollment metrics for sites requiring additional intervention.
Communicate with site staff to resolve issues related to missing, incomplete, or inaccurate submissions.
Participate in discussions related to site compliance, performance trends, and corrective actions.
Serve as a supporting contact for site questions when CRAs or CTMs are unavailable.
Assist with review and maintenance of site regulatory and study documents.
Help ensure accurate documentation in CTMS, TMF, and other study systems.
Participate in project team meetings and contribute to site issue resolution.

Requirements

Bachelor’s degree or nursing degree preferred.
2–4 years of experience in a clinical research setting.
Working knowledge of Good Clinical Practice (GCP) and applicable FDA and ICH regulations.
Strong organizational, communication, and problem-solving skills.
Proficiency in Microsoft Office (Outlook, Word, Excel).
Willingness to travel up to 80%, including international travel.
Ability to manage multiple tasks and adapt to changing priorities.
Ability to work independently and exercise sound judgment to appropriately escalate issues.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

endpoint data collectionsource document reviewdata assessmentSEEV reportingstudy recruitment metricssite regulatory document reviewCTMS documentationTMF documentationclinical research experienceproblem-solving

Soft Skills

organizational skillscommunication skillsproblem-solving skillsindependent worksound judgmentadaptabilitytask managementteam collaborationescalation managementsite issue resolution

Certifications

Bachelor's degreenursing degreeGood Clinical Practice (GCP) knowledge