Regulatory Associate
- Employer
- Compass Research
- Location
- The Villages, Florida
- Salary
- Starting at $40,000 annually
- Posted
- Sep 28, 2016
- Closes
- Nov 27, 2016
- Industry
- Healthcare
- Category
- Administrative, Clerical
- Contract Type
- Permanent
- Hours
- Full Time
- Career Level
- Experienced (Non-Manager)
Compass Research is actively seeking an experienced Clinical Research professional for its Regulatory department at its clinic in the Villages. Compass is an established, dynamic Clinical Research Company headquartered in Sunny Florida.
Primary Responsibilities:
Prepare regulatory documentation including regulatory and closeout submissions to the IRB
and/or Sponsor
Initiate, file, and maintain regulatory binders until study completion
Ensure deviations/violations/serious adverse events are dealt with and reported in a timely
fashion according to SOPs or IRB/Sponsor guidelines
Compile regulatory submissions to the Sponsor, CRO, or IRB in tandem with regulatory staff
Maintain IND Safety Reports and provide reports to the Principal Investigator and other staff as
necessary for review
Ensure IND Safety Reports have been reported to the IRB in a timely manner
Communicate to appropriate staff any revisions or updates to the protocol, investigator’s
brochure, or informed consent
Ensure current versions are utilized and obsolete versions discarded or filed
Communicate and update Sponsor with any revised site information and notify the IRB as
necessary
Liaison between the Site and Sponsor during monitoring visits and maintain regulatory
compliance at all times
Attend to any deficiencies or requests by Monitors or Sponsors and ensure any issues are
resolved as soon as possible but before the next monitoring visit
Schedule site initiation, monitoring visits, and closeout visits accordingly
Follow GCP, ICH Guidelines and Regulations and remain current with revised regulations
Update and maintain site records pertaining to the regulatory binder as necessary
Perform ad-hoc projects and/or general office duties as necessary
Knowledge, Skills, and Abilities
Learn and support the organization goals, missions, and values
Strong understanding and background of implementation of the regulations governing research
- State Law, FDA (CFR Title 21), ICH and GCP guidelines
Good interpersonal, planning/organizational, and communication skills (written and oral)
Ability to handle multiple tasks/projects simultaneously with minimal supervision
Attention to requisite details
Handles confidential information appropriately
Takes initiative and a team player
Knowledgeable with MS Office and Outlook
Prerequisites:
Minimum Associate’s Degree required
Minimum 2 years of experience working in a clinical research environment required