Clinical Research Coordinator

Summary:

Coordinating with the Principal Investigator, university, department, and central administration, the Clinical Research Coordinator helps to ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures. Assists in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to, but not limited to, protocol requirements, schedule of visits, execution of research plane. Maintains documentation of training. Other duties as assigned.

Typical Duties

Administrative:
-- Coordinates with Principal Investigator (PI) and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures.
-- Assists PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
-- Assists PI to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
-- Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
-- Collaborates with PI and institution to respond to any audit findings and implements approved recommendations.

Research:
-- Reviews and develops a familiarity with the protocol, eg: study proceedings and timelines, including and exclusion criteria, confidentiality, privacy protections.
-- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
-- Collects documents needed to initiate the study and submit to the sponsor (eg: FDA Forms 1572, CVs, etc.).
-- Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
-- Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
-- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
-- Registers participants to the appropriate coordinating center (if multi-site study).
-- Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
-- Coordinates participant tests and procedures.
-- Collects data as required by the protocol. Assure timely completion of Case Report Forms.
-- Maintains study timelines.
-- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or VCU Policy on investigational Drug/Device Accountability.
-- Completes study documentation and maintains study files in accordance with sponsor documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
-- Retains all study records in accordance with sponsor requirements and university policies and procedures.
-- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
-- Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
-- Assists the PI in submission of accurate and timely closeout documents to applicable federal agencies, university entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
-- Arranges secure storage of study documents that will be maintained according to university policy or for the contracted length of time, whichever is longer.
-- Assists in preparation of informed consent process.

Typical Education and Experience

Essential Qualifications:
-- Bachelor’s degree or equivalent related experience
-- Several years progressively responsible work experience
-- Formal clinical research education and experience
-- Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment
-- Demonstrated knowledge of medical terminology
-- Excellent discretionary decision-making skills
-- Independent, self-motivated, and organized
-- Detail-oriented; excellent problem-solving skills
-- Excellent written, verbal and interpersonal skills

Preferred Qualifications:

-- Experience in human subject research participants with neurological disorders
-- RN, NP or LPN eligible for license in Virginia or demonstrated clinical background
-- Familiarity with REDCap database
-- Experience administering validated survey instruments

Salary Range: $48,000 - $62,000



Position Details:

Department: School of Medicine, Neurology
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 100
Exemption Status: Exempt



Contact Information:

Contact Name: Denise Mitchell

Contact Email: denise.mitchell1@vcuhealth.org

Contact Phone: