Regulatory Specialist at Clinical… · Clearwater

Regulatory Specialist

Clinical Research of West Florida, Inc. – Clearwater, FL

The Regulatory Specialist will be responsible for establishing, maintaining, and providing administrative management of all site regulatory documents in accordance with Federal Regulations, ICH Guidelines, Good Clinical Practices, and CRWF Standard Operating Procedures.

Daily responsibilities include:

• Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (Google Cloud Platform) standards, Standard Operating Procedures (SOP's)

• Generates, facilitates, and maintains all study related regulatory documents from study start up through study close out, ensuring quality, accuracy, and timeliness

• Maintains study related documents in the CRWF electronic master file and regulatory binders

• Reviews all regulatory documents prior to Sponsor/Monitor visits

• Provides assistance to Sponsor representatives during monitoring visits

• Provides administrative and operational support to study coordinators, Investigators and other CRWF site staff

• Maintains record of site staff training and ensures protocol specific and internal training is maintained

• Serves as the CRWF liaison to sponsors, governing agencies and facilitates the transmission of verbal and written communication to pharmaceutical companies and other research entities as needed

• Prepares and maintains study records for archiving and/or retrieval

Additional requirements:

• Must be able to manage multiple ongoing projects at a time

• Must be detail oriented and highly organized

• Must be able to work independently

• Must be able to communicate effectively both verbally and in writing

• Must maintain a team attitude; many circumstances require interaction with the staff and physicians to ensure a positive outcome and work experience

• Historical regulatory experience preferred

• Proficient in Microsoft Word Suite (Outlook, Word, Excel)

• Qualifications: Must be able to manage multiple ongoing projects at a time; must be detail oriented and highly organized. Able to work independently and communicate effectively both verbally and in writing while maintaining a team attitude as many circumstances require interaction with the staff and physicians to ensure a positive outcome and work experience

Experience Required: Previous clinical research related experience.

Preferred Research Certifications (not required): CCRP, CCRC

With multiple offices located in Clearwater and Tampa, CRWF is an industry leader in the field of clinical research. The company has facilitated more than 1000 Phase I-IV research studies in various therapeutic areas. CRWF is dedicated to providing excellent patient care; board certified/eligible physicians along with an experienced, highly trained clinical staff conduct our studies.

EOE. Competitive Salary/Benefit Package. Comfortable, modern work environment. Friendly staff. The position is open for immediate employment.

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off

Experience:

• Clinical research: 2 years (Required)

Work Location: In person