Clinical Research Coordinator

Community Health Network; Indianapolis, Northern (IN, KY); Hybrid; USD 52,000 - 64,000; Full time

Job summary

Community Health Network in Indianapolis, IN seeks a Clinical Research Coordinator to assess, plan, implement and execute protocol-driven studies with the Principal Investigator and team. The role requires obtaining informed consent, maintaining data management systems, collecting data, preparing case report forms, and coordinating with sponsors and sites while upholding GCP, ICH and regulatory standards.

This full-time position offers opportunities to lead study activities, collaborate across

Qualifications

• Associate degree required; bachelor’s degree preferred.
• CCRA/CCRC/CCRP certifications within 3 years of hire.
• Minimum 2 years of related healthcare experience.
• Experience with data abstraction is helpful.
• Ability to obtain informed consent and manage data.

Responsibilities

• Identify and screen eligible candidates for study eligibility.
• Obtain informed consent from eligible patients for a study.
• Maintain an effective data management system to track participants and activities.
• Collect data and complete case report forms and data queries as specified by protocol.
• Prepare source documents for data collection.
• Assist in identifying study-related procedures for the project budget.
• Attend Investigator and Coordinator meetings and sponsor visits.
• Perform phlebotomy and ECG testing as trained.
• Process laboratory specimens for shipment per protocol; report results.
• Coordinate, implement and ensure compliance with GCP/ICH and regulatory standards.

Skills

Phlebotomy

ECG

Data collection

Source documentation

Communication

Education

Associate degree

Bachelor's degree

Job description

7979 Shadeland Ave Indianapolis , IN 46250 United States

Shift

Day Job

Hours

80 hours per pay period

Join Community

Community Health Network has an excellent opportunity available within our clinical research department. If you are looking for challenging work and meaningful advancement, then you should consider a career with Community.

Make a Difference

The Clinical Research Coordinator will be responsible for assessing, planning, implementing, and executing clinical research protocols in conjunction with the Principal Investigator and clinical research team

Your Exceptional Qualifications

Research Coordinator Duties: Identifies and screens appropriate candidates for eligibility for research studies. Obtains informed consent from eligible patients for a research study. Maintains an effective data management system to track study participants and activities. Collects data and completes case report forms and data queries as specified by the study protocol. Prepares source documents for data collection. Assists in identifying study related procedures for the project budget.

• Administrative Duties: Attends Investigator and Coordinator Meetings as requested by the sponsor along with appropriate department, division and/or service line meetings. Assists in determining facility, staff and supply needs required for set-up and implementation of a new study. Prepares for and is present for sponsor representative site visits. Serves as an educator and resource person for patients, family, staff and physicians.
• Laboratory Duties: Performs phlebotomy, ECG and other testing, as needed after trained. Prepares and processes laboratory specimens for shipment according to study lab manual. Reviews labs and ancillary tests; and reports results to Principal Investigator and appropriate personnel in timely manner.
• Interpersonal Skills: Effectively problem solves and informs Manager and Principal Investigator when appropriate.
• Communication: Communicates on a regular basis with the Investigators, Research Team, Hospital Staff, Monitor and other sponsor representatives to ensure adherence to Good Clinical Practice (GCP) guidelines.
• Safety & Compliance: Coordinates, implements and completes clinical research studies in accordance with protocol guidelines, GCP, ICH, local, state and federal standards. Monitors adherence to protocols, and reports violations in a timely manner to the sponsor and the IRB.
• Individuals may not perform all of these duties, or may perform additional, related duties not listed here.

EDUCATION

• 2 year / Associate Degree (Required)
• 4 year / Bachelor's Degree (Preferred)
• In lieu of the above education requirements, a combination of experience and education will be considered.

LICENSE & CERTIFICATION REQUIREMENTS

• within three (3) years from hire Certifications/Licensures: (Certified Clinical Research Associate (CCRA - ACRP), Certified Clinical Research Coordinator (CCRC-ACRP), Certified Clinical Research Professional (CCRP-SoCRA))

EXPERIENCE

• Previous experience in data abstraction is helpful (Preferred)
• Minimum of 2 years in a related field of healthcare (Required)

Why Community?

At Community Health Network, we build teams that deliver exceptional care through empathy, communication and collaboration. We consider ALL an integral part of the exceptional patient experience. We PRIIDE ourselves on not having employees but Caregivers. Join our Community as we make a difference in your community.