Clinical Research Site Lead

5 hours ago

Lagrange, Maine, United States Rovia Clinical Research Full time

About Us

At Rovia Clinical Research, we're shaping the future of community clinical research by being the partner of choice for CROs, Sponsors, and PIs. Our team of skilled professionals includes talented and driven individuals from all backgrounds.

People First – Humility – Integrity – One Team – Results Accountability

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.
  • Strong regulatory experience highly preferred.
  • 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.

The pay range for this role is:

65, ,000 USD per year(ECIR - Jefferson City)

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