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University of Rochester Regulatory Coordinator - 228639 in Rochester, New York

Regulatory Coordinator Job ID 228639

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Cancer Center/Clin Trials Ofc

Schedule

8 AM-4:30 PM

Responsibilities

CORE JOB SUMMARY:

The Regulatory Maintenance Coordinator will be responsible for the day to day operations of the maintenance phase of all assigned protocols.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Documents amendments in REDCap tracking system

  • Collect all regulatory documents required to submit to the DWG and PRMC, as applicable

  • Prepare/draft ICF and insert institutional language; ensuring language consistent with protocol

  • Collect and maintain all essential regulatory documents within Complion

  • Coordinate and validate the delegation log with Clinical Trial Manager

  • Confirm profile page, licenses, certifications, etc. are all current and up to date

  • Prepare and track/guide submission to IRB (CIRB, RSRB, Commercial IRB, FDA, ClinicalTrials.gov, etc.)

  • Liaise with other required stakeholders and committees (HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc.)

  • Enter and load all required information to OnCore and Complion

  • Liaison with Sponsor regarding maintenance of protocols

  • Attend Pre SIV and SIV

Professional Development

  • Coordinates with collaborating services/departments in protocol planning, implementation, and evaluation

  • Schedules and participates in Site Initiation Visits (SIV) and participates in research team and PI oversight meetings as required

  • Coordinates regulatory team meetings; assures communications across-the-board

  • Provides leadership in problem solving logistical challenges to assures study objectives are achieved according to protocol and projected time-line

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

COMPETENCIES AND SKILLS:

  • Demonstrated leadership skills and competency

  • Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards

  • Detailed-oriented in record keeping and research documentation

  • Proficiency in oral and written communication skills

  • Proficiency in managing multiple and competing priorities/demands

  • Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation

  • Ability to effectively manage moderately complex research protocols/procedures

  • Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork

  • Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)

  • Possesses a high degree of self-motivation; recognized ability to function independently.

  • Proficiency in use of software applications: databases, spreadsheets, word processing

  • Fluent English language skills required (oral and written)

QUALIFICATIONS:

Education:

  • Bachelors degree

  • Mandatory CITI training prior to participating in any research-related procedures

  • Certified in Healthcare Research Compliance by the Health Care Compliance Association, or similar preferred

Work Experience Requirements:

  • Minimum of 1 year of clinical research or relevant work experience

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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