Study Coordinator

ECLARO; Chapel Hill (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) Retirement Savings Plan

Commuter Check Pretax Benefits

Medical, Dental & Vision Insurance

Job summary

ECLARO is seeking a Study Coordinator for our client in Chapel Hill, NC to independently coordinate and manage multiple oncology clinical trials throughout the study lifecycle. You will work with Principal Investigators, sponsors, and clinical teams to ensure trials adhere to protocol, GCP, and regulatory requirements.

Responsibilities include site visits, enrollment, data collection, biospecimen handling, and audits.

Qualifications

• Experience as a study coordinator or in oncology clinical trials.
• Familiar with Phase I-III clinical research including investigational drugs/devices.
• Experience coordinating complex studies independently.

Responsibilities

• Independently manage multiple oncology clinical trials from startup through closeout.
• Maintain understanding of assigned study protocols and sponsor requirements.
• Coordinate activation, implementation, monitoring, and closure activities.
• Participate in site initiation visits, startup meetings, monitoring visits, and closeout visits.
• Maintain study documentation and regulatory records.
• Identify, screen, recruit, and enroll eligible research participants.
• Conduct informed consent discussions and document patient participation.
• Coordinate protocol-required study visits and data collection.
• Enter study data into electronic data capture systems and case report forms.
• Resolve data queries within established timelines.
• Coordinate collection, processing, storage, and shipment of research specimens.
• Ensure compliance with GCP, FDA and Federal Regulations.
• Track time and effort reporting; support administrative functions.
• Collaborate with investigators, sponsors, and clinic staff; train new members.

Skills

Clinical Research Expertise

Operational Skills

Communication & Collaboration

Job description

Be at the forefront of innovation. ECLARO is looking for a Study Coordinator for our client in Chapel Hill, NC. The client is a notable public research university. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview

• The Study Coordinator is responsible for independently coordinating and managing multiple oncology clinical trials throughout the study lifecycle, including activation, enrollment, conduct, monitoring, and closure.
• This position works closely with Principal Investigators, research staff, sponsors, and clinical teams to ensure studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies.
• The role requires direct patient interaction and coordination of research activities across Client Medical Center, Client Campus Locations, and Affiliated Clinics.
• Exposure to bloodborne pathogens, biohazardous specimens, and other healthcare-related materials may occur as part of normal job responsibilities.

Responsibilities

• Clinical Trial Coordination:
  • Independently manage multiple oncology clinical trials from startup through study closeout.
  • Maintain a comprehensive understanding of assigned study protocols and sponsor requirements.
  • Coordinate study activation, implementation, monitoring, and closure activities.
  • Participate in site initiation visits, startup meetings, monitoring visits, and closeout visits.
  • Maintain study documentation and regulatory records.
• Participant Recruitment and Management:
  • Identify, screen, recruit, and enroll eligible research participants.
  • Conduct informed consent discussions and document patient participation.
  • Coordinate and schedule protocol-required study visits.
  • Provide participant education and study-related support.
  • Monitor participant safety and communicate study requirements throughout participation.
• Data Collection and Documentation:
  • Maintain accurate and complete source documentation.
  • Enter study data into electronic data capture systems and case report forms.
  • Resolve data queries within established timelines.
  • Maintain screening logs, enrollment records, and study tracking tools.
  • Create and review study-specific source documents and data collection materials.
  • Participate in routine monitoring visits and audits.
• Biospecimen and Laboratory Support:
  • Coordinate collection, processing, storage, and shipment of research specimens.
  • Maintain specimen accountability and tracking documentation.
  • Collaborate with investigators and laboratory personnel regarding specimen analysis and study requirements.
  • Ensure compliance with biohazard handling and shipping procedures.
• Regulatory Compliance:
  • Ensure compliance with GCP, FDA and Federal Research Regulations, Institutional Review Board (IRB) Requirements, Sponsor Requirements, Client Policies and Procedures.
  • Report serious adverse events within required timelines.
  • Assist with protocol deviation reporting and corrective action plans.
  • Prepare for and support study monitoring visits and audits.
• Financial and Administrative Responsibilities:
  • Review billing calendars and study-related financial documentation.
  • Submit participant reimbursement paperwork.
  • Ensure study visits are linked appropriately within the electronic medical record system.
  • Track time and effort reporting as required.
  • Support study-related administrative functions and reporting.
• Team Collaboration:
  • Serve as a primary contact for assigned clinical trials.
  • Work collaboratively with investigators, sponsors, research staff, nursing teams, and clinic personnel.
  • Assist in training and onboarding new staff members.
  • Support development of investigator-initiated studies and study materials.
  • Participate in process improvement and quality initiatives.

Skills

• Clinical Research Expertise: Must have experience as a study coordinator or in oncology clinical trials, with strong preference for those familiar with Phase I-III clinical research including investigational drugs and devices and translational trial experience. Prior involvement coordinating complex studies independently is preferred.
• Operational and Analytical Skills: Strong computer skills, ability to manage multiple projects, demonstrated decision-making and problem-solving capabilities, high attention to detail in data gathering and documentation.
• Communication and Collaboration: Effective verbal and written communication skills, customer-oriented mindset, ability to work collaboratively in a team environment.

Benefits

• 401(k) Retirement Savings Plan administered by Merrill Lynch.
• Commuter Check Pretax Commuter Benefits.
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO.

ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.