Compliance Specialist

Virginia, United States
Salary Not Specified
May 27, 2021
Employment Type
Full Time

Position Information

University Code 25211 University Title Auditor 1 University Job Family Legal, Audit & Compliance ORP Eligible No For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Job Series Scope of Search Regional Working Title Compliance Specialist Position Number 586140 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Massey Cancer Center Organizational Overview

At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.

Position Primary Purpose and General Responsibilities

Massey Cancer Center seeks an experienced, driven Compliance Specialist. The chosen candidate will:
Deliver exceptional compliance support to the Principle Investigator (PI) and research team with delivery of quality auditing, monitoring and DSMC coordination ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant safety and welfare.

Coordinate, schedule and conduct routine, for cause and not for cause audits for the Massey Cancer Center Clinical Trials Office ( CTO ).

Schedule and conduct monitoring visits for Massey Cancer Center greater than minimal risk investigator initiated trials, consortia trials, and other trials as determined by CTO physician leadership.

Provide administrative support to the Massey Cancer Center Data and Safety Monitoring Committee ( DSMC ) and Committee Chair as warranted.

Schedule and conduct quality control reviews for NCTN trials being conducted at VCU MCC and across its affiliate network.

Schedule and conduct annual quality assessments as needed for trials conducted at VCU MCC .

Minimum Hiring Standards

Knowledge of human subject clinical research procedures.

Demonstrated working knowledge Good Clinical Practices ( GCP ), International Committee on Harmonization ( ICH ) guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.

Demonstrated initiative in maintaining professional development in the clinical research and human research arena by reading relevant literature, attending meetings, etc.

Knowledge of clinical research compliance, regulatory and NCI audit guidelines and best practices.

Solid knowledge base of medical terminology, and oncology research, or readily transferable medical / health care experience.

Experience in a medical or academic research setting.

Prior experience auditing clinical trials preferred.

Prior experience in a clinical research environment preferably as a clinical research associate, monitor, site coordinator and/or regulatory coordinator.

Prior experience with early phase investigator-initiated oncology trials preferred.

Extensive computer experience, including database, spreadsheet, and Word Processing, with interest to attain knowledge in other software as needed.

Excellent organizational, communication and interpersonal skills.

Excellent written and oral communication.

Experience using a Clinical Trial Management System ( CTMS ) required, Prior experience with any phase of clinical database design or maintenance (database specification, build, testing, data entry, data locks, data quality checks and validation, data extraction, etc.)

Prior experience with electronic clinical data capture systems and process.

Prior experience with audit preparation and chart reviews.

Prior experience maintaining audit ready research subject patient charts or actual participation

Hands-on experience with Data and Safety Monitoring Committee ( DSMC ) and audit chart review.

Ability to analyze data and independently generate reports.

Exceptional analytical and organizational skills.

Ability to travel to network component site locations across the state for auditing with occasional overnight travel.

Ability to interpret federal, state, and protocol sponsor policies and regulations as required.

Proven ability to work in a demanding, fast paced environment with frequent ambiguous direction and a requirement to deliver service and support with accuracy, high quality and attention to detail.

Ability to balance a voice of professional assertiveness with “go with the flow” in order to get things done.

Ability to deliver audit/monitor/review findings objectively and demonstrate genuine intent to assist Principal Investigator (PI) and research staff in development of corrective action plans as needed.

Ability to think strategically and make decisions.

Ability to write reports and review data to identify trends.

Abiilty to work in a diverse environment.

Ability to travel to partner sites across the country for monitoring visits as required.

Preferred Hiring Standards

BA/BS degree in health science field or related discipline or equivalent training and experience.

OnCore experience

Current SOCRA CCRP, ACRP CCRC or other clinical research or clinical research regulatory professional certification. If not currently certified, will be required to take certification examination within six months of hire into position or when next certification exam is being conducted at VCU .

Required Licenses/ Certifications Anticipated Hiring Range commensurate with experience Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours 8-5, M-F Job Open Date 05/27/2021 Posting will close on or before Open Until Filled No Job Category Is this a restricted position? No Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link Posting Specific Questions

Required fields are indicated with an asterisk (*).

  1. * Briefly describe your understanding of the general role and purpose of an auditor within the clinical research trial environment.

    (Open Ended Question)

  2. * Briefly describe your understanding of the Institutional Review Board in relation to human research subject's protection.

    (Open Ended Question)

  3. * Briefly describe your experience working in a regulated work environment or job (ex: type of work you did; how it was regulated; was it audited, etc)

    (Open Ended Question)

  4. * Briefly identify/describe three (3) key members of a clinical research team.

    (Open Ended Question)

  5. * What habits or routine practices do you have that keep you organized at work?

    (Open Ended Question)

Optional & Required Documents
Required Documents Optional Documents
  1. Cover Letter/Letter of Application
  2. Other Document
  3. Resume

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