Clinical Research Coordinator 3

Position Summary:

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.

Duties/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 Skills/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.

Education/Experience:

• 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. 
• 3+ years of CRC experience preferred, preferably working on industry-sponsored trials.
• License/Certification status with appropriate CEUs, if applicable.
• Current cardiopulmonary resuscitation (CPR) certification.
• Current International Air Transport Association (IATA) certification.
• Current Good Clinical Practice (GCP) certification.