Clinical Research Coordinator I

Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basics tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level

Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume 2-10 annually.

Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures.  Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

• Identify and explain key protocol elements and perform study tasks under direct supervision

• Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires

• Identifies and explains inclusion/exclusion criteria and the process of subject identification, prescreening, screening and re-screening

• Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process.

• Review of diagnostic tests and related documentation required per protocol

• Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Document different types of adverse events under direct supervision

• Ensures proper storage, dispensing, handling and destruction processes for investigational products.

• Follows process for handling investigational products that have been compromised. 

• Follows Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site. Maintains site credentials and ensures updated GCP, licenses remain on file   

• Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.

• Collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy under direct supervision

• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials

• Prepare documents for monitoring visits under direct supervision.  Review visit monitoring follow-up reports / letters and perform requested activities.

• Escalates issues of protocol non-compliance to study PI and research department leadership

• Identifies elements of a study budget as it relates to execution of a protocol.

• High school education required

• Some college is preferred

• Prior research or related medical science experience

• Proficiency in MS Office Word, Excel, Power Point, and Outlook required.

• Prior experience with electronic medical records (EMR) is preferred

• Prior experience with clinical trial data entry systems (EDC) preferred

• Prior Clinical Trial Management Systems (CTMS) preferred.

Standard Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM.