Clinical Research Coordinator: School of Medicine, Neurology

Full Time
Richmond, VA
Posted Today
Job description

Virginia 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/

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. 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
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.

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 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.

Minimum Qualifications
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.

Preferred Qualifications
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 Requirements
Special Instructions to Applicants Please apply online on company site at:
https://vcu.csod.com/ux/ats/careersite/1/home/requisition/2213?c=vcu

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

Intrested in this job?

Related Jobs

All Related Listed jobs

Marufuku Ramen Redwood Redwood City, CA 94063 Today

POPULAR RESTAURANT * GOOD TIPSWe are looking to hire Server to join our talented team.We work as a team, and team members are expected to perform variety of cross-functional tasks as needed to

Accura HealthCare of Le Mars Le Mars, IA 51031 Today

Accura HealthCare of Le Mars is a 46 bed SNF. We are always looking for great nurses, regardless of FT, PT and PRN potential, to join our team. We offer a collaborative, family oriented, team

Texas Tech Unv Hlth Sci Ctr El Paso El Paso, TX 8 days ago

Patient Services Specialist (Internal Medicine). This position is responsible for assuring smooth operation of the clinic patient flow.

Legal Sea Foods Framingham, MA 01702 Today

We are looking for a Busser to support our wait staff and set up our dining areas. Busser responsibilities include serving plates, glasses and silverware, refilling beverages and cleaning tables. If

OSU Physicians Columbus, OH 43221 $86,250 - $143,749 a year 30+ days ago

Notify physician of need and follow up with patient according to provider instructions as necessary. Knowledge of triage procedures along with clinic, physician

Who Are We? WASTE CONNECTIONS, Inc. (NYSE: WCN): is a non-hazardous solid waste services company that provides solid waste collection, transfer, disposal, and recycling services in the U.S. and

Walt Disney World Resort Orlando, FL 32802 Today

Monorails Cast Members are focused on creating magic for our Guests during their Walt Disney World Resort stay by ensuring the highest standards of safety while piloting, loading/unloading,

Century Communities Greenwood Village, CO 80111 Today

About Century Communities As a top 10 U.S. homebuilder and industry leader in online sales, we know what it takes to be a market gamechanger, and that includes providing you with all the

Nebraska State College System Wayne, NE 68787 Today

Nature of Work This is an advanced classification that performs specialized clerical work of an administrative nature of varied scope and complexity

City of Pacific Grove Pacific Grove, CA 93950 Today

SummaryTHE COMMUNITY: The Police Department commitment to excellence, respect, professionalism, and integrity through collaborative community partnerships promotes a high quality of life in our town