Clinical Research Coordinator II

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

Under minimal supervision and direction will be responsible for the coordination and administration of multiple research studies. Responsible for assigned research studies and general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical conditions and diagnoses.

Job Description:

1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations:

• Ensures adherence to regulations.

• Educates and mentors other study staff as applicable.

2) Responsible for coordinating different phases of research studies with varying degrees of complexity with minimal oversight:

• 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.

3) Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:

• 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.

4) Conducts assigned research studies per protocol requirements, departmental and institutional policy:

• Creates and maintains eRegulatory, patient study and CRF files.

• Thoroughly learns assigned protocols and 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.).

• 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 with the coordination of preparing summary reports, study results, poster presentations and manuscripts for publication.

5) Recruits patients to assigned research studies: