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Hourly Clinical Research Coordinator | School of Medicine, Neurology
4 months ago
Primary responsibilities will include, but not limited to:
Administrative
Coordinates with Principal Investigator 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 the 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 Principal Investigator 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 implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Research
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion 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 (e.g., 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. Assures 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 requirements and University policies and procedures including, but not limited to, consent forms, source 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 Principal Investigator 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.
Minimum Education and Experience
Bachelors degree or equivalent combination of education and experience Excellent written, verbal and interpersonal skills Self-motivated candidate with exceptional attention to detail and robust problem solving abilities
Preferred Experience
Experience in human subjects research with neurological disorders RN, NP or LPN - eligible for license in VA preferred Demonstrated clinical background Experience with phlebotomy Familiarity with REDCap database and video editing software Experience administering validated survey instruments
The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.
This position is open until filled.
ORP Eligible: No
This is a restricted position with no set end date and continued employment is dependent upon project need, availability of funding, and performance.
University Position: Clinical Research Coordinator 1-3
Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.
Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.
