Clinical Research Coordinator

Responsible for the performance of the research study under the medical supervision of the Principal Investigator.  Clinical Research Coordinator II (non-RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work

Primary responsibility includes complex types of study designs (phase 1-3, multi-cohort, interventional trial design) and associated study procedures. Administratively and clinically manage an average 10 clinical trials open to accrual annually and/or active (on study treatment) patient volume over 25 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.

• Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures.  Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.

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

• Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently.

• Reviews draft informed consent documents in compliance with regulatory requirements and GCPs.  Conduct an informed consent discussion in compliance with SOPs

• Review and interpret diagnostic test results 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. Recognize, report and follow up on all types of adverse events

• Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens.

• Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised.

• Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site.  Complete all IRB/IEC-related documents over the course of a clinical study. 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.

• Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy.

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

• Manage a monitoring visit including appropriate preparations, support, documentation and follow up.  Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests

• Implement a CAPA assessment and follow CAPA related issues through to resolution.

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

• Assess a protocol and study plan to develop a study budget. 

• Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. 

• 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.

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