Job Title: Clinical Research Coordinator

Job Description

As a Clinical Research Coordinator, you will serve as the primary coordinator for clinical research studies, responsible for enrolling patients, creating source documentation, and developing internal processes. Your role will include performing lab procedures such as phlebotomy and ECG, collecting data, creating data report forms, and maintaining communication with study sponsors. You will lead 3-5 studies and manage approximately 5 patients per week, engaging in both drug and device studies.

Responsibilities

• Identify and screen suitable candidates for research studies.
• Obtain informed consent from eligible patients for participation in research.
• Maintain effective data management systems to track study participants and activities.
• Collect data and complete case report forms as specified by study protocols.
• Prepare source documents for data collection.
• Assist in identifying study-related procedures for project budgeting.
• Attend Investigator and Coordinator Meetings as requested.
• Determine facility, staff, and supply needs for new study setup and implementation.
• Prepare for and attend sponsor representative site visits.
• Serve as an educator and resource for patients, families, staff, and physicians.
• Perform phlebotomy, ECG, and other tests as needed after training.
• Prepare and process laboratory specimens for shipment according to study protocols.
• Review laboratory and ancillary tests, reporting results to the Principal Investigator and appropriate personnel.
• Problem solve effectively and communicate with the Manager and Principal Investigator when necessary.
• Regularly communicate with Investigators, Research Team, Hospital Staff, Monitors, and sponsors to ensure adherence to Good Clinical Practice (GCP) guidelines.
• Coordinate, implement, and complete clinical research studies in accordance with protocol guidelines, GCP, ICH, local, state, and federal standards.
• Monitor adherence to protocols, reporting violations in a timely manner to the sponsor and IRB.

Essential Skills

• Effective communication skills, both oral and written.
• Proficiency in navigating Electronic Medical Records (EMRs), preferably Epic.
• Ability to work flexible hours if needed.
• Basic computer skills.
• Strong customer service skills.
• Teamwork skills.
• Must have 2+ years of Clinical Research Coordinator experience.

Additional Skills & Qualifications

• Associate Degree required; Bachelor's preferred.
• Cardiology experience highly preferred, but strong research experience in other therapeutic areas will be considered.
• CCRC certification required within three years of hire.

Work Environment

The work schedule is flexible, typically 9-5 or 8-4. Work will be conducted primarily at the main location, with occasional duties at other locations to cover for other coordinators. Mileage reimbursement will be provided if travel occurs. The role offers long-term growth opportunities.