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University of Rochester Health Project Coord - 227810 in Rochester, New York

Health Project Coord Job ID 227810

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

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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