o Collect, prepare, and submit documentation to various sponsors/CROs during study start- up, including:
o Submission documents/approvals
o Protocol amendments with respective signature pages
o Informed consent documents
o FDA form 1572 o Lab normal result documents
o Financial disclosure forms
o Delegation of authority logs
o Licenses, Reports, Logs
- Collect, prepare, and submit documentation to institutional review boards for all ongoing and new trials.
- Serve as a liaison between the IRB, site, and investigator
- Obtain necessary signatures from investigators
- Coordinate contracts with third-party vendors
- Maintain and track current staff credentialing (i.e., CV, certifications, etc.)
- Act as a resource to other staff members with regulatory questions
- Adhere to existing standard operating procedures, perform training on SOPs for the staff, and draft new SOPs when necessary.
- Maintain regulatory documents for ongoing trials, and ensure all appropriate regulatory documents are archived at the conclusion of the study.
Qualifications
- At least 2 years of relevant work-related regulatory experience in clinical research.
- Knowledge of “good clinical practices” for clinical research as defined by the Code of Federal Regulations (CFR).
- Demonstrated organizational skills to provide regulatory support efficiently and effectively for multiple clinical trials and projects, providing accurate information in a timely manner.
- Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
- Knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
- Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
- Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
- Must be self-directed and be able to manage multiple projects and responsibilities.
- Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.
- A critical thinker with strong attention to detail and superb problem-solving abilities.
Compensation: $28-32/h.
COVID-19 vaccination is strongly recommended at CenExel Clinical Research and all its research sites. As permitted by applicable law, COVID-19 vaccination may be required for employees that work directly with patients.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.