Aug 01, 2021

RESEARCH REGULATORY SPECIALIST

  • BayCare Health System
  • Tampa, FL, USA

Job Description

RESEARCH REGULATORY SPECIALIST(

Job Number:

217989)

Description

Responsible for ensuring their assigned research team members, investigators and associated portfolio of clinical research projects are in compliance with all applicable institutional, sponsor and governmental policies and laws. Acts as a liaison between the sponsor, Clinical Research Operations, Institutional Review Board and internal departments/ staff to complete initial Institutional Review Board protocol submissions, submit study amendments in a timely fashion including changes to the protocol, consent forms and other study documents, prepare for and facilitate monitoring visits, ensure study regulatory files are up to date & audit ready, maintain regulatory master files for industry & investigator initiated clinical trials, aid in the development of protocol specific standard operation procedures, and develop & train Clinical Research Coordinators on guidelines related to consent, ethical conduct and protection of human subjects. Preferred Certification includes SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research professionals) or CCRC (Certified Clinical Research Coordinator). Required Education and Experience includes Bachelor's Degree in in Business, Healthcare Management, Nursing or related and 5 years of research regulatory experience OR High School Degree and 10 years of research regulatory experience. Additional Specific Skills includes extensive knowledge of FDA regulation and human subjects protection.

Qualifications

Certifications and Licensures
PreferredReference summary for details

Education
RequiredBachelor'sReference summary for details
OrReference summary for details
PreferredMaster'sRelated Field

Experience
Required5 yearsReference summary for details
OrReference summary for details

Specific Skills
RequiredCustomer service skills
RequiredWritten and verbal communication skills
RequiredInterpersonal skills
RequiredDelegation skills
RequiredWork independently
RequiredWork with a team
RequiredCritical thinking skills
RequiredOrganizational skills
RequiredAdministrative and clerical skills
RequiredComputer skills appropriate to position
RequiredKnowledge of regulatory standards appropriate to position
RequiredMedical terminology use and understanding

Organization

: 0030-BC HOSPITAL SUPPORT SVCS LLC

Primary Location

: FL-Tampa-St. Joseph's Hospital
Schedule: Monday, Tuesday, Wednesday, Thursday, Friday

Shift

: Days
Shift Hours: 8:00 am to 4:30 pm
Weekend Work: None
On Call: No
Employment Status: ACTIVE FULL TIME

Equal Opportunity Employer Veterans/Disabled