CLINICAL RESEARCH COORDINATOR
PURPOSE
To work as an integral member of the Rovia/Investigator site staff, maintaining the day-to-day operations and assist in the development of the Rovia network. This includes planning, coordinating, and executing clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and Rovia SOPs and any relevant local guidelines and regulations.
Responsibilities
- Manages site selection visits and coordinates study startup activities (e.g., Source Data ID log, recruitment plan, site blinding plan, and temperature log).
- Oversees facility issues in collaboration with the Site Manager and Director, and leads weekly site meetings.
- Manages investigator signature processes and supports study recruitment and contingency planning.
- Monitors and tracks pre-screening, enrollment efforts, and progress toward study enrollment goals, addressing delays or changes promptly.
- Identifies difficult-to-enroll studies and collaborates with the recruitment manager to improve enrollment.
- Ensures timely data entry in EDC and Clinical Conductor platforms and resolves any issues.
- Leads or attends study initiation, interim monitor, and close-out visits.
- Reviews site monitor reports, follows up on action items, and conducts quality checks on subject visits.
- Collaborates with site managers and compliance teams to identify and address quality issues.
- Works with the Source Document Specialist to ensure source documents are ready for patient visits.
- Provides support and guidance to site research staff, including training, troubleshooting, and resource management.
- Acts as a liaison between the site, financial team, and management, and suggests improvements to workflows.
- Develops and maintains investigator relationships, providing regular progress reports.
- Onboards and trains new staff, tracks their progress, and addresses gaps in training.
- Participates in site staff evaluations and new employee interviews.
- Serves as a mentor and fosters a positive work environment.
- Conducts presentations at company training events and collaborates on external relationships for specialized study protocols.
- Supports special projects, business development, team building, and writing SOPs.
- Perform other duties as assigned.
Required Knowledge, Skills And Abilities
- Sound knowledge of medical terminology.
- Sound knowledge of ICH/GCP and Regulatory requirements.
- Excellent interpersonal and organizational skills.
- Proficient in the use of Microsoft Office and Excel.
- Fluent in spoken and written English.
- Ability to work independently and in a team environment.
- Ability to maintain confidentiality.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Minimum Required Education, Experience And Certifications
- High school diploma required, bachelor’s degree in related field of study preferred.
- Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or within 6 months of role acceptance.
- 2+ years of CRC experience required, preferably working on industry-sponsored trials.
- Experience in clinical research quality and/or regulatory processes preferred.
- License/Certification status with appropriate CEUs, if applicable.
- Cardiopulmonary resuscitation (CPR)
- International Air Transport Association (IATA)
- Good Clinical Practice (GCP)
Job Type: Full-time
Benefits
- Paid time off
- Flexible schedule
- Advancement opportunities
- 401(k) with company match
- Health, dental, and vision insurance
- HSA with company match
- Life and disability coverage
- Employee referral program
Schedule
- Day shift
- Monday to Friday, 8:30AM-5:00PM