Clinical Research Coordinator VA
A clinical research coordinator who supports your research site or sponsor remotely: regulatory submissions, participant tracking, eCRF data entry, query resolution and visit scheduling. Studies stay on protocol, on timeline and inspection-ready.
- Top 1% vetted talent
- No lock-in contracts
- Replacement guarantee
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Hourly rates · No lock-in contracts
Description
A Clinical Research Coordinator VA supports research sites, CROs or sponsors with regulatory documents, participant tracking, eCRF data entry, query resolution and visit scheduling. They can also help prepare for monitoring visits and maintain study records to ICH-GCP standards. Outsource Teams provides top 1% vetted talent with clinical research coordination experience, no lock-in contracts and a replacement guarantee.
Responsibilities
- Prepare and maintain regulatory documents including IRB and ethics submissions, informed consent versions, delegation logs and the site regulatory binder.
- Enter and reconcile study data in electronic data capture systems such as Medidata Rave, Veeva Vault, Oracle Clinical or REDCap, and resolve data queries within sponsor timelines.
- Track participant screening, enrolment, visit windows and retention, and schedule visits and follow-ups with participants and site staff.
- Prepare for monitoring visits and audits by keeping source documents, drug accountability logs and training records complete.
- Report adverse events and protocol deviations to the principal investigator, sponsor and IRB within the required timeframes.
- Coordinate study start-up tasks such as feasibility questionnaires, budgets, contracts and site initiation logistics.
- Maintain the study's essential documents in the electronic master file to ICH-GCP standards.
- Liaise with sponsors, CROs, labs and vendors on shipments, supplies and study communications.
- Support participant communication, reminders and stipend tracking where the protocol allows remote contact.
- Protect participant data under HIPAA, GCP and the study's confidentiality requirements.
Software & Tools
Requirements
- At least 5 years of clinical research coordination experience across multiple study phases, at a site, CRO or sponsor.
- Nursing, pharmacy, life sciences or allied health degree; CCRC (ACRP) or CCRP (SOCRA) certification is preferred.
- Current ICH-GCP training and working knowledge of FDA 21 CFR Parts 50, 56 and 312 or the equivalent regulations in the client's country.
- Hands-on experience with EDC and eTMF systems such as Medidata Rave, Veeva Vault and REDCap, and with CTMS platforms.
- Meticulous documentation habits and the ability to explain a deviation clearly and honestly in writing.
- Professional English for sponsor correspondence, monitoring visits and participant contact.
- HIPAA training completed.
- Reliable high-speed internet with backup power, available during the client's site or sponsor business hours.
Frequently Asked Questions
What study tasks can they support?
They can manage regulatory documents, data entry, participant tracking, visit scheduling, query resolution and study start-up tasks.
Can they help prepare for monitoring visits?
Yes. They can maintain source documents, accountability logs, training records and other materials needed for monitoring and audit readiness.
What systems can they use?
They can work with REDCap, Medidata Rave, Veeva Vault, OnCore and Microsoft Excel.
How experienced are the candidates?
Candidates are expected to have at least five years of clinical research coordination experience across multiple study phases.
How much does it cost?
Rates are listed in USD at $9 per hour for entry-level talent, $12 per hour for intermediate and $15 per hour for senior talent. Both full-time and part-time options are available.
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