Clinical Research Coordinator II, Cardiology

Job Description

Possesses ongoing knowledge of FDA, OHRP and GCP regulations:

• Ensures adherence to regulations.
• Educates and mentors other study staff as applicable.

Responsibilities

Coordinating and administering multiple research studies:

• Completes and submits trial feasibility forms; coordinates and obtains non-disclosure agreements.
• Arranges and conducts pre-study qualification and site visits.
• Acts as the main liaison of communication between sponsors and investigators in all aspects of study start up.

Implementing assigned research studies:

• Implements all study protocols in accordance with research SOPs, FDA, OHRP, and GCP regulations.
• Immediately develops coordinator/sponsor relationship.
• Completes start-up checklists and organizes study start-up plan, including source worksheet creation.
• Prepares, completes and submits regulatory documents in a timely manner.
• Prepares, completes and submits start-up IRB documents in a timely manner.
• Reviews all pertinent study documents for potential implementation issues and implements plan accordingly.
• Ensures appropriate training and certification for all members of the study team involved in the research protocol.
• Establishes and communicates study procedures with collaborating departments to ensure compliance with all study requirements; conducts in-services (e.g. arranges special blood draws with phlebotomy, special blood processing with specimen processing, ordering and receiving of drug with the pharmacy and infusion team, and copying and submission of MRI with Radiology).
• Works collaboratively with research finance to process clinical trial agreements, study budget development and other finance issues, as applicable.
• Attends Investigator Meetings as applicable.

Conducting assigned research studies per protocol requirements:

• Creates and maintains eRegulatory, patient study and CRF files.
• Serves as resource for all study team members.
• Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
• Advises physicians on required tests, timing of tests and procedures.
• Ensures that all appropriate treating physicians receive the results of study tests, as appropriate.
• Administers questionnaires and assessments as mandated by the protocol and delegated by the PI.
• Directly retrieves and/or coordinates the retrieval and submission of patient samples or tests (e.g., blood samples, urine samples, tissue, ECG, etc.).
• SUBMITTED: Submits all IRB submission documents such as protocol amendments and consent form revisions, annual reviews, adverse events, investigator changes, accrual status change and change in risk to the IRB in a timely manner with minimal assistance/guidance from senior staff; Complies with IRB decisions, conditions and requirements.
• Utilizes current systems to schedule tests and appointments and to access patient data and test results.
• Establishes monitoring tools to ensure the adherence to study guidelines (e.g. patient enrollment tracking).
• MAY ASSIST: May assist with the coordination of preparing summary reports, study results, poster presentations and manuscripts for publication.

Recruiting patients to assigned research studies:

• Works closely with physicians to develop recruitment strategies.
• Creates research brochures and other related recruitment materials; creates and/or reviews study trial listing for the Lahey website.
• Works closely with physicians to develop recruitment strategies.
• Creates research brochures and other related recruitment materials; creates and/or reviews study trial listing for the Lahey website.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.
• Works closely with physicians to develop recruitment strategies.