Regulatory Associate

Compass Research is actively seeking an experienced Clinical Research professional for its Regulatory department at its headquarters in Downtown Orlando. Compass is an established, dynamic Clinical Research Company headquartered in Sunny Orlando, 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