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Clinical Research Coordinator

Richmond

Clinical Research Coordinator

  • req618
  • Richmond, Virginia, United States, 23284
  • Neurology / 1590
  • Virginia Commonwealth University
Clinical Research Coordinator

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. VCU School of Medicine comprises 18 clinical departments, eight basic health science departments, and 11 affiliated institutes and centers, and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. 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

This position serves as a coordinator for the Translational Research Program in Muscular Dystrophy. This program is responsible for developing disease modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective.

For all clinical research studies assigned, the Clinical Research Coordinator is responsible for coordinating clinical research studies in a compliant and efficient manner. Under the direction of the Principal Investigator (Pl), collaborates with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept.

Duties and Responsibilities

20% - General / Administrative

• For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, research participant scheduling, ordering of study materials and supplies, and schedule of meetings
• Coordinate and/or prepare and collect all necessary study documentation which may include: feasibility forms, pre-screening logs, screening logs, enrollment logs, medication log, adverse event log, delegation of authority log, training logs, etc.
• Design and implement optimal systems to identify potential research subjects for assigned studies.
• Support the orientation and training of new research team members and other staff.
• Follow all university and School of Medicine procedures for activation and management of clinical research.
• As requested, provide financial staff with information/data to aid in financial management activities.
- Perform other duties as needed. Accept alternate assignments gracefully.

20% Regulatory and Compliance Requirements

- Understand and adhere to all human subject protection and IRB regulations required for clinical research. Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns.
- Participate in meetings with internal and sponsor appointment monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
- Coordinate auditing and monitoring activities for assigned studies.

20% Data Management

- Assist the Pl and senior study team members in the management of study data for new and ongoing clinical research studies assigned.
- Maintain study files according to GCP guidelines and in audit ready condition.
- For assigned studies, ensure subject data is entered into sponsor case report forms, databases, and VCU’s OnCore system in a timely manner and in accordance with sponsor and university/school.
- Review and respond to all sponsor query replies within required time frames, seeking input from Pis and other study staff as appropriate.

20% Study Contact

- Coordinate subject recruitment activities: pre-screening, screening.
- Access allowable data capture/retrieval systems and interact with a variety of health care delivery system to identify potential study participants.
- Conduct informed consent process for research participants under Pl supervision.
- Coordinate the registration and enrollment of participants, coordinate and file
registration/randomization documents; notifying applicable/allowable individuals of registration/randomization results (Pl, participant, study team, pharmacist, etc.)
- Support the Pl and other senior study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements.
- Work with Pl to ensure all required study close-out activities are completed.

20% Clinical Skills

- Complete VCUHS orientation and training modules as required for the department & clinical research projects. Conduct applicable clinical activities only as approved & required for each clinical research project.
- Any clinical skill must be conducted in VCUHS approved clinical areas only. Any protocol required clinical skill requires current VCUHS competency verification/documentation prior to performing each activity.
- Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills.
- Cannot perform any tasks that by state or local law require a license to perform, unless such license is on file and approved by VCU/VCUHS.
- Phlebotomy, vital signs, electrocardiograms, and point of care testing will be a routine part of the job; hence the requirement for formal clinical education, experience, and an active license.

Essential Qualifications
Minimum 2 years prior experience. Formal clinical education and experience also required (RN, LPN, CNA, or CMA) with active license. Ability to work in a diverse environment.

Preferred Qualifications
Experience in human subjects research with participants with neurological disorders. Clinical Research Coordinator certification is preferred (CCRC, CCRP, CCRA). Phlebotomy skills. Familiarity with REDCap database and video editing software. Experience administering validated survey instruments.

Required Licenses/Certifications
RN, LPN, CNA, or CMA with active license

This is a restricted position with no set end date; continued employment is dependent upon project need, availability of funding, and/or performance.

Position will remain open until filled.

UNIVERSITY TITLE: CLINICAL RESEARCH COORDINATOR 1-3

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.

 

Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer

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