Protocol Implementation Coordinator

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor's degree in biological sciences, health sciences, social sciences, human ecology, or medical field., One year of experience in planning and administration of research projects., Considerable knowledge of clinical research regulations and compliance issues preferred., Computer literacy and experience with Microsoft Office applications required..

Key responsabilities:

  • Serve as the principal liaison between the Clinical Trials Office, protocol sponsor, and Principal Investigator.
  • Track protocol progress through the activation phase and provide status reports to the study team.
  • Schedule and facilitate Sponsor Site Initiation visits and CTO Implementation meetings.
  • Participate in database development, data entry, and quality assurance.

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Job description

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Job Title:
Protocol Implementation Coordinator

Department:
CCC | Clinical Trials Office

Job Description

Functions as a Protocol Implementation Coordinator (PIC) who will work to assure that Clinical Trials Office (CTO) research protocols within the Comprehensive Cancer Center are activated in compliance with Federal, State and University regulations and departmental policies; serves as the principal liaison between the CTO, protocol sponsor, Principal Investigator (PI) and other hospital departments to ensure applicable trial information is communicated to appropriate personnel; serves as initial and primary liaison to Industry Sponsors during the protocol trial implementation phase, communicating trial progress, initiating the resolution of any questions or problems that arise, and completing the timely submission of sponsor-required start-up documents; schedules and facilitates Sponsor Site Initiation visits, CTO Implementation meetings, and ensures all required activities are completed prior to opening trials to accrual; tracks each protocols progress through the activation phase, working closely with the CTO Regulatory team and the Office of Contract Development and Coordination (OCDC) and provides progress status reports to the study team; provides regular updates to  CTO Clinical Research Managers on pending trials, communicates trial projected openings and tracks the status of pre-pending trials being reviewed by each disease team; provides protocol timeline activation reports to the Comprehensive Cancer Center (CCC) Leadership and the study team; participates in database development, data entry and quality assurance.

Minimum Education Required

Bachelor's degree in biological sciences, health sciences, social sciences, human ecology or medical field or an equivalent combination of education & experience required.

Qualifications

One year of experience in planning and administration of research projects required; considerable knowledge of clinical research regulations, guidelines and compliance issues preferred; understanding of medical knowledge preferred; computer literacy and experience utilizing Microsoft Office applications required.

Additional Information:

As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies – providing tomorrow’s standard of care today.  A Cancer-Free World Begins Here. 

Location:
Remote Location

Position Type:
Regular

Scheduled Hours:
40

Shift:
First Shift

Final candidates are subject to successful completion of a background check.  A drug screen or physical may be required during the post offer process.

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The university is an equal opportunity employer, including veterans and disability. 

Required profile

Experience

Industry :
Education
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Microsoft Office
  • Quality Assurance
  • Problem Solving

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