The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring a Regulatory Associate . As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the Regulatory Associate is responsible for providing support to the Clinical Operations team for multi-center clinical trial activities from concept to close-out. Dedication to accuracy, high attention-to-detail, and ability to work independently are critical competencies for the role. This is an excellent opportunity to become part of an engaging and growing clinical research team.
You will: - Partner with Project Associates to maintain comprehensive, GCP/FDA compliant, regulatory files for protocols.
- Support Quality Control through support of the PCCTC monitoring program.
- Perform regular audits to ensure that regulatory documentation is complete, up-to-date, and accurate and to ensure that the TMF is in compliance with regulatory agency requirements. Perform audits to ensure site qualifications are maintained throughout the duration of a study.
- Prepare for internal and external audits of a protocol (e.g. conduct pre-audit review of the regulatory files).
- Perform a complete Quality Assurance review of all regulatory documents in line with plans to close sites and/or studies.
- Manage the PCCTC electronic TMF system, including system user management and system functionality assessment, implementation, and oversight. Support program-level TMF structure development and management and study-specific TMF setup.
- Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the conduct of a clinical study.
- Complete all required certifications per company requirements (e.g., Human Subjects Protection, HIPAA), and ensure research team compliance of such trainings for all involved in the clinical trial.
You need: - A bachelor's degree and 2-4 years of relevant clinical research experience or a High School Diploma with at least 4-7 years clinical research experience.
- Working knowledge of the Code of Federal Regulations, Good Clinical Practice, and Human Subjects Protection.
- Comfortable working in a dynamic environment.
- Strong organizational, prioritization, and project management skills.
- Strong computing skills including proficiency in MS Office products.
- Excellent social, verbal and written communication skills.
- Ability to tackle problems by using a logical, systematic, sequential approach.
More information about the PCCTC:
The Prostate Cancer Clinical Trials Consortium (PCCTC) was initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. Established as an independent entity in 2014, the PCCTC, LLC is now the nations best-in-class multicenter Clinical Research Organization (CRO) specializing in ground breaking prostate cancer research. The PCCTC works together with distinguished investigators on a single mission: to design, implement and complete hypothesis-driven early phase trials in prostate cancer, translating scientific discoveries to improved standards of care. To fulfill its mission, the PCCTC developed a rare infrastructure, which has nurtured a culture of clear project co-development between investigators, research sites and industry partners. |
