Job descriptionVirginia Commonwealth University ( VCU ) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. All full-time university staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/
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. Insures subject safety first and foremost, by writing and carefully complying with Institutional Review Board (IRB) protocols, and assisting others to do the same. Maintains rigorous documentation of subject enrollment, participation and adverse events in the research database. 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 plan. Maintains documentation of training. Helps in submission of grant applications. Other duties as assigned.
Responsibilities and Duties
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.
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.
Reviews and develops a familiarity with all protocols, 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.
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 IRB requirements and approvals.
Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria.
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.
Assists in preparation and execution of informed consent process.
Approaches and communicates with subjects in a compassionate and humane manner appropriate for age, that may span childhood through late adulthood.
Coordinates participant tests and procedures.
Conducts study visits and implements all study visit procedures in a compassionate and efficient manner and in accordance with IRB regulations.
Ensures imaging data are collected as detailed in imaging protocols
Oversees back‐up of all imaging data files for later retrieval and analysis.
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.
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.
Bachelor’s degree or equivalent related experience
Several years progressively responsible work experience
Formal clinical research education and experience
Independent, self‐motivated, organized and compassionate in character.
Excellent written, verbal and interpersonal skills
Demonstrated knowledge of medical terminology
Excellent discretionary decision‐making skills
Detail‐oriented; excellent problem‐solving skills
Ability to work in a fast‐paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment
Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
Experience in human subject research participants with pain disorders
RN, NP or LPN eligible for license in Virginia
Familiarity with REDCap database
Experience administering validated survey instruments
Special Instructions to Applicants Please apply online on company site at:
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 is a restricted position with no set end date; continued employment is dependent upon project need, availability of funding, and performance.
ORP Eligible: No
Position is open until filled; priority application review date is August 22, 2022
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