Documentation Control Specialist Job in Miramar 33027, Florida US
Comprehensive Clinical Development (CCD) formerly known as Comprehensive NeuroScience, Inc. (CNS) provides early phase pharmacology and specialty clinical trials. CCD plays a key role in advancing the development of innovative drugs and treatments for humans. With locations from coast to coast, CCD is a trusted provider to many of the world’s leading pharmaceutical companies, setting the highest standards in service, reliability and quality. Please visit our website at: www.comprehensivecd.com
JOB SUMMARY:
The Document Control Specialist is responsible for establishing, maintaining and archiving a filing system that supports the Trial Master File (TMF) in accordance with federal regulations, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCPs) and CCD (SOPs). This position is an integral member of the study, PM, Clinical Services, and corporate teams.
QUALIFICATIONS:
Education: Bachelor’s degree in a health related field or ACRP CCRC or SOCRA CCRP
certification.
Required Experience:
- Experience in organizing documents, TMF preferred, in a health care environment.
- Minimum three (3) years of experience in the pharmaceutical industry, supporting clinical
study conduct in an operational or training capacity and/or experience in a medically
related profession or a pharmaceutical or medical device company or as a clinical research coordinator at an investigative site.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: ACRP CCRC or SOCRA CCRP certification preferred.
Please forward resume to Zlall@cnsmail.com