Clinical Research Regulatory Coordinator

Under the direct supervision of the Project Manager, the Clinical Trials Regulatory Research Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. Key to this role is the preparation of clinical trial protocols and related regulatory documents for submission to the Human Research Protections Program (Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed.

The Clinical Trials Regulatory Research Associate will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, IRB, and the CTO. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, IRB staff, study sponsors and/or their representatives. This position may assist with study data collection and other duties assigned as needed.

Minimum Qualifications

• Ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
• Experience with editing, including summarizing information into concise and condense documents.
• Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.
• Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or Bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs.
• Experience working and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are not clear.
• Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.
• Knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
• Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
• Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Ability to maintain confidentiality.

Preferred Qualifications

• Experience interpreting medical charts and abstracting data from medical records in relation to study subject screening.
• Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
• Experience creating Informed Consent Documents that comply with HRPP/ IRB policies and procedures, FDA regulations, and sponsor requirements.
• Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
• Working knowledge of Human Research Protections Program (HRPP/IRB) policies and Procedures.
• Knowledge of oncology and hematology.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check and pre-employment physical.
• Must be available to work occasional evenings and weekends (may include attending PRMC meetings twice per month, as needed).
• Must be able to maintain strict confidentiality.