Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance to appropriate regulations, Standard Operating Procedures (SOP'S), and study specific protocols/plans and processes under the direct supervision of the Regulatory Compliance Manager.
PATIENT AGE GROUP SERVED
Indirect patient care.
DUTIES AND RESPONSIBILITIES
Assure compliance of general and study-specific regulatory and/or safety related processes with SOP's, FDA, GCP, NIH and applicable regulations.
Responsible for assisting in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors, submits adverse event reports, submits safety reports, and notifies IRB of study closures.
Build and maintain effective relationships with key study personnel.
Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues.
Act as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested.
Maintain the required regulatory files for all clinical trials to ensure regulatory compliance. Meet with study monitors. Maintain archived documents on and off site.
Prepare and manage FDA documents required to initiate investigational drugs trials.
May interface with appropriate governmental agency on project/products as identified by the Manager. Assist in the preparation of periodic reports for FDA.
Maintain a professional and credible image with FDA and other regulatory agencies, Sponsors, vendors, patients and co-workers.
Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager.
Maintains accountability for own ongoing professional growth and development.
Displays ICARE values.
Perform other duties as assigned.
Bachelor's degree or 30 hours college coursework preferred
3 year relevant research program experience
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
RAPS, CCRC, or CCRP is preferred.
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Working knowledge of FDA regulations and GCP guidelines.
Excellent written and oral communication skills.
Ability to multi-task.
Organizational skills and attention to detail.
Critical thinking ability.
Strong analytical skills.
Document management skills.
Proficient computer skills.
Office and clinic environment. Travel not required.
Houston Methodist - 2 years ago
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