Clinical Research Coordinator

Community Health Network • Indianapolis, IN

1d

About The Position

The Clinical Research Coordinator assesses, plans, implements, and executes clinical research protocols in conjunction with the Principal Investigator and clinical research team. The role coordinates research activities in line with study protocols, Good Clinical Practice (GCP), ICH, and applicable local, state, and federal standards. Duties may vary, and additional related responsibilities may be assigned.

The coordinator identifies and screens potential study participants, obtains informed consent, maintains study tracking and data management systems, collects data, completes case report forms and data queries, and prepares source documents. The role also supports study budgets and start-up needs, prepares for sponsor site visits, communicates with investigators and research stakeholders, and serves as a resource for patients, families, staff, and physicians.

Laboratory responsibilities may include phlebotomy, ECGs, other testing after training, specimen preparation and shipment, and timely review and reporting of laboratory and ancillary test results. The coordinator monitors protocol adherence and reports violations to the sponsor and IRB in a timely manner.

Requirements

• Associate degree required; a combination of education and experience may be considered in lieu of the stated education requirements.
• At least 2 years of experience in a related healthcare field required.
• Obtain one of the listed certifications/licensures within three years of hire: Certified Clinical Research Associate (CCRA—ACRP), Certified Clinical Research Coordinator (CCRC—ACRP), or Certified Clinical Research Professional (CCRP—SoCRA).

Nice To Haves

• Bachelor's degree preferred.
• Previous experience in data abstraction preferred.

Responsibilities

• Assess, plan, implement, and execute clinical research protocols with the Principal Investigator and clinical research team.
• Identify and screen candidates for eligibility for research studies.
• Obtain informed consent from eligible patients.
• Maintain a data management system to track study participants and activities.
• Collect data and complete case report forms and data queries according to study protocols.
• Prepare source documents for data collection.
• Assist in identifying study-related procedures for project budgets.
• Attend investigator and coordinator meetings requested by sponsors and appropriate department, division, or service-line meetings.
• Assist in determining facility, staff, and supply needs for setting up and implementing new studies.
• Prepare for and attend sponsor representative site visits.
• Educate and serve as a resource for patients, families, staff, and physicians.
• Perform phlebotomy, ECGs, and other testing as needed after receiving training.
• Prepare and process laboratory specimens for shipment according to study lab manuals.
• Review laboratory and ancillary test results and report them promptly to the Principal Investigator and appropriate personnel.
• Problem-solve effectively and inform the Manager and Principal Investigator when appropriate.
• Communicate regularly with investigators, the research team, hospital staff, monitors, and sponsor representatives to support adherence to GCP guidelines.
• Coordinate, implement, and complete studies in accordance with protocol guidelines, GCP, ICH, and applicable local, state, and federal standards.
• Monitor protocol adherence and report violations promptly to the sponsor and IRB.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree