Clinical Operations Specialist
Provide regulatory essential document guidance to clinical sites and program team members in accordance with ICH/Good Clinical Practice (GCP) Guidelines, Code of Federal Regulations and company SOPs and requirements. Provide operational support to the Clinical Program Teams.
Job Details/Main Responsibilities
1. Manage Essential Document completion and provide regulatory guidance to clinical sites and program team members during the start-up, maintenance and close-out phases of a study.
2. Develop and negotiate Informed Consent development with clinical sites.
3. Compile and distribute Site Regulatory Binders.
4. Set-up Trial Master File (TMF), TMF filing and maintain documents by reviewing for accuracy and appropriateness for filing.
5. Investigator Site File reviews and technical quality control activities in order to maintain complete and current versions of all essential regulatory documents during the course a study to ensure files are audit or FDA inspection ready.
6. Coordinate Study Level Central IRB submissions via upload or email.
7. Periodically update ClinicalTrials.gov database.
8. Audit and update clinical tracking systems.
9. Perform operational tasks to support clinical operations teams with study execution as needed.
10. Achieve objectives for independent projects which may include data monitoring and source document verification.
11. Actively participate in collaborative efforts and clinical operational decision-making.
12. Perform other duties as assigned.
Education & Experience
Bachelor’s Degree or Associates Degree with previous clinical research experience.
License or Certification
CCRP or CCRA preferred.
Knowledge, Skills, Abilities
Working knowledge of Microsoft Office. General knowledge of FDA/EMEA regulations as well as ICH/GCP Guidelines. Good knowledge of medical terminology. Excellent oral/written/interpersonal communication skills to communicate internally and externally. Excellent Microsoft Office skills. Strong attention to detail. Ability to set priorities and work in a fast-paced, multi-study environment.
To apply, please send a cover letter and resume to [email protected] and indicate the job title in the Subject line.