Responsible for submitting protocols to the Insitutional Review Boards for research and maintaining accurate protocol files. 

Education and/or Other Requirements

High school graduate or equivalent with general businesses courses.  Prefer two to five years experience as administrative assistant.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

• Excellent word processing skills.  Experience with computer databases and medical terminology.  Experience with adobe acrobat and internet.  Must be able to communicate effectively and to organize and prioritize work.

Environmental Factors

Minimal exposure to irritating, unpleasant, or hazardous elements or conditions.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Light physical exertion, including occasional standing, bending, reaching and occasional carrying of light loads.

Mental Demands

• While performing the duties of this job, the employee must be able to work under stress due to increased work load and to exercise appropriate independent judgment.

• Ability to adhere to strict confidentiality requirements.

Note

Reasonable accommodations may be made to assist an otherwise qualified individual in the performance of the job.  In order to meet the needs of the Company employees may be assigned other duties, in addition to or in lieu of those described above.

Essential Functions and Job Duties

• Coordinates and/or prepares materials for timely submission to the IRB for the research office.

• Retrieves protocol documents from each research base, either electronic or paper.
• Reviews new protocol submissions and makes necessary modifications required by the local IRBs.
• Accurately completes required IRB forms prior to IRB submission; summarizes protocol revisions; summarizes SAE reports.
• Requests required PI signatures.
• Submits documents to IRB Administrators.
• Communicates and coordinates with research bases and pharmaceutical companies to ensure proper materials are submitted and filed.

• Organizes and maintains protocol files, including central office, physician offices, radiation oncology, pharmacy, and DMH oncology department, and disseminates protocol documents to appropriate staff in a timely manner.

• Keeps accurate records of protocol activities and IRB submissions.

• Enters protocol information into research database.
• Tracks protocols to ensure timely submissions for annual reviews.
  • Gathers information needed to complete annual review.
  • Forwards necessary information/completed forms to appropriate staff for review and finalization of annual reviews.

• Completes and maintains drug accountability logs forms (DARFs) for the DMH pharmacy and the CCSCI pharmacy.

• Collaborates with other staff to ensure ALL protocol information is organized and completed. Serves as a back up to other Regulatory Compliance Coordinators in their absence.  Communicates with Director and staff in regards to any protocol activation delays or problems.

• Prepares records for audits. Records are assessable and organized for research base, pharmaceutical, and FDA audits.

• Performs other duties as assigned.