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Clinical Research Coordinator

East Coast Institute For Research

Georgia (VT)

On-site

USD 60,000 - 80,000

Full time

5 days ago
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Job summary

A prominent clinical research organization is seeking a Clinical Research Coordinator to oversee day-to-day operations and coordinate clinical studies. In this full-time role, you will manage site activities, support recruitment efforts, and ensure compliance with all regulatory guidelines. Your expertise will help maintain effective relationships with various stakeholders while fostering a positive and collaborative work environment.

Benefits

Paid time off
Flexible schedule
Advancement opportunities
401(k) with company match
Health insurance
Dental insurance
Vision insurance
HSA with company match
Life and disability coverage
Employee referral program

Qualifications

  • 2+ years of Clinical Research Coordinator experience required.
  • Licensure and certification in CPR and IATA preferred.
  • Familiarity with clinical research quality and regulatory processes.

Responsibilities

  • Manage site selection visits and coordinate study startup activities.
  • Monitor and track enrollment efforts and address enrollment delays.
  • Support study recruitment and ensure timely data entry.

Skills

Medical Terminology
Interpersonal Skills
Organizational Skills
Confidentiality
Teamwork

Education

High school diploma
Bachelor's degree in related field
Certification as CCRP or CCRC

Tools

Microsoft Office
Excel

Job description

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
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