Clinical Research Coordinator

Community Health Network; United States; On-site; USD 52,000 - 72,000; Full time

Job summary

Community Health Network is seeking a Clinical Research Coordinator to assess, plan, implement, and execute clinical research protocols with the PI and team. Role involves candidate screening, consent, data management, data collection, and budget support.

Qualifications include 2-year/Associate or 4-year/Bachelor's degree, CCRO/CCRA/SoCRA certifications preferred, and healthcare experience. Requires performance of phlebotomy, ECG, and lab specimen handling.

Qualifications

• Identifies and screens candidates for eligibility in research studies.
• Obtains informed consent from eligible participants.
• Maintains data management systems to track study participants and activities.
• Collects data and completes case report forms per the study protocol.
• Prepares source documents for data collection.
• Assists with study budget procedures and related tasks.
• Attends sponsor and departmental meetings as requested.
• Performs phlebotomy, ECG, and other testing after training.
• Prepares and ships laboratory specimens per lab manuals.
• Reviews labs and reports results to the PI promptly.
• Communicates with Investigators, Research Team, and sponsor to ensure GCP adherence.
• Coordinates studies to ensure protocol, GCP, ICH, and regulatory compliance.

Responsibilities

• Identifies and screens candidates for eligibility.
• Obtains informed consent from eligible patients.
• Maintains data management systems to track study participants.
• Collects data and completes case report forms per protocol.
• Prepares source documents for data collection.
• Assists with study budget procedures.
• Attends sponsor/department meetings as requested.
• Performs phlebotomy and ECG as trained.
• Prepares and ships laboratory specimens.
• Reviews labs and reports results to PI promptly.
• Communicates with Investigators and sponsor to ensure GCP adherence.
• Coordinates studies to ensure regulatory compliance.

Skills

Data management

Informed consent

Phlebotomy

Laboratory testing

Education

Associate Degree

Bachelor's Degree

Job description

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 r esponsible 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)