Clinical Research Coordinator, Parkinson's & Movement Disorders Center - SOM / Neurology

Summary

For all clinical research studies assigned, the Clinical Research Coordinator (CRC) is responsible for coordinating clinical research
studies in a compliant and efficient manner. Under the direction of the Principal Investigator (PI), the CRC will collaborate 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. Key responsibilities include:
• Management of all duties required for clinical research studies from initiation to close-out.
• Conduct of clinical research activities as authorized by the Principal Investigator’s documented Delegation of Authority and Training Logs.
• On-call coverage for research projects as needed,
• Collaboration with department administrative staff and the School of Medicine Office of Research Administration, coordination of the initiation processes for Movement Disorders research projects and other clinical research projects in the Department of Neurology;
• Maintenance of current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understanding and adherence to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved
protocols.
• Conducting all assigned activities in compliance with national, local, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
• Study activities including coordinating new study activation requirements, screening/enrolling participants, regulatory and compliance requirements, maintaining appropriate study documentation/records, and managing study data.

Duties and Responsibilities

Research and Clinical Trials Coordination:

-- Independently coordinate the activities of clinical trials. Includes on-call responsibilities as needed for studies.

-- Travel to attend informational meetings regarding studies as needed.

-- Coordinate study process from inquiry to initiation to close-out. Screen, recruit, and enroll subjects on clinical research studies. Coordinate study procedures, visits, and follow-up activities. Meet with participants at clinical service locations as indicated/required.

-- Conduct and document the initial and ongoing informed consent process throughout the study participation and follow-up. Manage evaluation of potential participants for clinical trial eligibility. Register/Enroll participant as assigned.

-- Manage and file registration/randomization documents. Notify all applicable/allowable individuals of registration/randomization results (PI, participant, study team members, Pharmacist, Physician,
etc.).

-- Follow study participant through all study activities to ensure that study is conducted in compliance with all requirements as assigned. Educate potential participants and monitor participant activity and responses throughout the study conduct.

-- M anage collection, including via phlebotomy, processing and shipping of lab specimens as required.

-- Collaborate with and educate all study team members, physician, nurses and other applicable disciplines to ensure that all protocol activities are implemented as required.

-- Serve as a resource to study participants, significant others and related disciplines as applicable.

-- Document all study activity according to ALCOA standards (Attributable, Legible, Contemporaneous, Original, Accurate).

-- Provide assessment of study participant, including monitoring and initial assessment and grading of Adverse Events, Serious Adverse Events, and Unanticipated Problems. Report applicable AEs, SAEs, UPs to Investigator, sponsor and all applicable entities. Supply AE documentation to PI for final sign-off of AE reporting.

-- Collaborate in Coverage Analysis (CA) and billing plan assessment and verification. Participate in the central coordination of multi-site clinical trials.

-- Follow all university, school, and department procedures for activation and management of clinical research.

New Study Activation

-- Search for new funded research opportunities.

-- Manage site selection visits and study selection activities.

-- Manage Study Finding activities – May include database searches, contact with sponsors, CROs, etc. Implement Site Selection processes (Coordinate CDA process, sponsor questionnaires, site selection visits.) Manage preparation and collection of all necessary Source Documents as above

-- Collaborate with PI and oversee study team members to verify that all study documents are complete, accurate and ready for use prior to enrolling participants.

-- Provide education to and document training of all team members and related disciplines. Provide study education to all applicable disciplines and individuals prior to implementing clinical research activities.

-- Participate in Investigator Initiated Clinical Research study and document development, including Protocol/Research Plan, Informed Consent Form, Participant training materials, etc. Prepare Order templates.

Data Management

-- Responsible for coordination and supervision of the completion of source documents.

-- Manage Case Report Form, data queries, and responses to queries. Input data into clinical trial electronic submission forms according to FDA specifications and drug manufacturer protocols.

-- Maintain study documentation and files. Manage subject data entry that supports accurate billing, including OnCore data entry, entering data in a timely manner and reviewing OnCore data and clinical invoicing with fiscal personnel as necessary to ensure accuracy and completeness.

-- Facilitate signatures and form completion for study close-out procedures. Archive data per protocol and institutional requirements. 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 –level requirements.

Regulatory and Compliance Requirements

-- Manage reporting of all required information to Regulatory team, including, but not limited to: Initial submissions, Amendments/Revisions, Annual reviews, Staff changes, Protocol deviations/violations, Serious Adverse Events (SAEs), Unanticipated Problems (UPs),

-- Sponsor Safety Reports, Corrective Action Plans, others as applicable. Manage and maintain current Adverse Event, Serious Adverse Event and communicate to regulatory team.

-- Ensure compliance with federal, local and institutional regulations through ongoing communication with VCU Office of Human Subjects Protection and all applicable entities.

-- Participate in Auditing and Monitoring activities as indicated. Manage all audit and monitor findings and responses as required. Participate in quality assurance systems to ensure accurate and high quality data collection practices.

Education and Outreach

-- Coordinate and participate with education and outreach initiatives, community activities for patients and other activities.

Risk Management

-- Demonstrates a commitment to risk assessment (considering cost, benefit, and impact) -utilizes identified internal control mechanism -practices routine verification of the accuracy of data

Other Duties

-- 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. Follow all VCUHS requirements for training to acquire and maintain access to VCUHS clinical systems and clinical data.

-- Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills. Job duties may include the handling, transportation, access to and/or contact with medications and related supplies. 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.

-- Perform other duties as needed, as directed by supervisor.

-- Cross-cover for other department research coordinators as needed.

Essential Qualifications

-- Bachelor’s Degree or equivalent related experience.

-- Several years of progressively responsible work experience.

-- Must be able to complete mandatory competencies and certifications required by VCU, individual clinical trials, and the NIH Human Subject Protection training required by federal regulations for research.

-- Communication skills, written and spoken are essential.

-- 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

-- CCRC (Certified Clinical Research Coordinator), phlebotomy experience, and experience and ability to assist
with acquisition and analysis of research MRIs and EEGs.

-- Prior study management and/or neurological patient care experience preferred.

Position is open until filled

ORP eligible: No

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

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/

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.

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.

UNIVERSITY JOB CODE: Clinical Research Coordinator 1-3 (34111-34113)

Salary Range: $50,000 - $60,000/annually



Position Details:

Department: Neurology / 1590
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1
Exemption Status: Exempt



Contact Information:

Contact Name: Michael Czuba

Contact Email: michael.czuba@vcuhealth.org

Contact Phone: