Regulatory Document Specialist

Full-time, 40 Hours/Week

Monday to Friday, 8am - 4:30pm

Remote (Onsite as needed)

Summary:

Provides regulatory support to investigators conducting clinical research. Coordinates with study teams to ensure appropriate oversight and compliance with all Federal, State and Local regulatory requirements for mandated regulatory documents utilized in clinical research conducted by the RDCRI.

Responsibilities:
1.Protocol processing

2.Preparation of informed consent documents to comply with local policies

3.Preparation for IRB submission

4.Prepare and submit sponsor's essential regulatory documents

5.Process IRB submission and approvals

6.Preparation and maintenance of Regulatory Binders

7.Strategic review of the regulatory binders prior to monitoring visits

8.Other duties as required.

Other information:

Technical Expertise

1. Experience interacting with study monitors and FDA reviewers.

2. Knowledge of GCPs, SOPs, and regulatory documents required for clinical trials.

3. Demonstrates organizational and time management/prioritization skills.

4. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.

5. Proficiency in the English language with excellent use of grammar and spelling is essential.

6. Demonstrates effective communication skills for relating to and networking with all levels of personnel.

7. Demonstrates organizational and time management/prioritization skills.

8. Knowledge of medical terminology and diseases.

Education and Experience

1. Education: High school diploma and a minimum of four (4) years experience OR Associates Degree and minimum two (2) years experience OR Bachelor's Degree and minimum one (1) year experience working in a direct or related clinical trial setting.

2. Licensure: None

3. Certification: None

4. Years of relevant experience: One or more

5. Years of supervisory experience: None

Full Time

FTE: 1.000000