Job Title: Clinical Research Data Coordinator
Job Location: New Haven, CT 06510
Job Duration: 3+ months (High Possibility of Long-Term Extension)
Pay Range: $34.00 to $40.00/hour on W2.
Shift: Day 5x8-Hour (08:30 AM - 04:30 PM)
Job Description:
- Candidates must be able to work independently and contribute immediately to reducing a backlog of clinical research data.
- Experience with Electronic Data Capture (EDC) systems, including Veeva Vault, Medidata Rave, Dosima, or similar platforms, is highly preferred.
POSITION SUMMARY:
We are seeking an experienced Clinical Research Data Coordinator to provide immediate, hands-on support with clinical data management while additional Research Assistants are onboarded and trained. This individual will play a key role in reducing a backlog of approximately 263 delinquent study visits requiring data entry and reconciliation while ensuring timely, accurate, and compliant study data across multiple active clinical research studies. The ideal candidate has experience working in clinical research, is proficient in Electronic Data Capture (EDC) systems, and can independently review source documentation, investigate discrepancies, and respond to sponsor/CRO data queries in a fast-paced research environment.
REQUIRED QUALIFICATIONS:
EDUCATION
- High School diploma or GED required.
- Associate's or Bachelor's degree in Life Sciences, Healthcare, or a related field preferred.
EXPERIENCE:
- 3–5+ years of experience in clinical research data management, clinical research data entry, or as a Clinical Research Coordinator (CRC), Clinical Research Assistant (CRA), Clinical Data Coordinator, or a similar clinical research role.
- Experience entering and maintaining clinical trial data within Electronic Data Capture (EDC) systems.
- Experience reviewing source documentation for completeness, accuracy, and protocol compliance.
- Experience responding to sponsor and/or CRO data queries and making appropriate data corrections.
- Ability to investigate discrepancies, resolve data issues, and manage multiple priorities independently in a fast-paced research environment.
CERTIFICATIONS:
- GCP, CCRC, CCRP, or other clinical research certifications preferred, but not required.
TECHNICAL SKILLS:
- Experience with Electronic Data Capture (EDC) systems, including:
- - Veeva Vault EDC
- - Medidata Rave
- - Dosima
- - Other comparable EDC platforms
- Microsoft Office Suite (Excel, Outlook, Word)
OTHER REQUIREMENTS:
- Exceptional attention to detail and commitment to data accuracy.
- Strong analytical and problem-solving skills.
- Ability to work independently with minimal supervision.
- Excellent written and verbal communication skills.
- Ability to collaborate effectively with study coordinators, investigators, sponsors, and research teams.
- Ability to manage competing priorities while maintaining data quality and study timelines.
KEY RESPONSIBILITIES:
- Enter clinical research data from paper source documents into Electronic Data Capture (EDC) systems.
- Review source documentation for completeness, accuracy, and protocol compliance prior to data entry.
- Investigate discrepancies, missing information, and inconsistent documentation to ensure accurate study data.
- Work collaboratively with study teams to clarify and resolve data issues before entry.
- Respond to sponsor and study monitor (CRO) data queries by reviewing source documentation, providing responses, and making data corrections as needed.
- Assist with reducing the current backlog of approximately 263 delinquent study visits requiring data entry and reconciliation.
- Support ongoing participant visits to ensure study data remains current while new Research Assistants are onboarded and trained.
- Maintain compliance with Good Clinical Practice (GCP), sponsor requirements, and clinical research documentation standards.
- Contribute to improving overall data quality, reducing delinquent visits, and ensuring timely completion of study documentation.
Pay: $38.00 - $40.00 per hour
Application Question(s):
- How many years of experience do you have in clinical research data management, clinical research data entry, or as a Clinical Research Coordinator (CRC), Clinical Research Assistant (CRA), or Clinical Data Coordinator? Please describe your most recent role.
- Which Electronic Data Capture (EDC) systems have you used (e.g., Veeva Vault, Medidata Rave, Dosima, Oracle InForm, REDCap, or similar), and what were your primary responsibilities using these systems?
- Do you have experience reviewing source documents, entering clinical trial data into EDC systems, investigating data discrepancies, and responding to sponsor or CRO data queries? Please provide an example.
- Have you worked on clinical trials while ensuring compliance with Good Clinical Practice (GCP), study protocols, and regulatory requirements? If yes, please describe your experience.
- This role requires managing multiple studies, reducing data-entry backlogs, and working independently with minimal supervision. Can you describe a time when you successfully managed competing priorities while maintaining data accuracy and meeting deadlines?
- What is the best time to speak with you over the call to discuss more about this opportunity?
Work Location: In person
