Coordinator-Regulatory II - BCRI Baptist Clinical Research

Summary

Responsible for supporting all activities related to the regulatory process as completed by the CTC department. Ensures compliance with regulatory agency regulations and sponsor and departmental standard operating procedures. Works under the supervision of the regulatory manager and performs tasks as assigned. Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. Performs other duties as assigned.

Responsibilities

• Provides support for the regulatory process from receipt of documents to preparation of all required documents for sponsor and IRB submission.
• Ensures timely posting, notification and filing of protocol amendments, updates and revisions for all trials.
• Maintains regulatory binders by ensuring all documents are present and filed correctly.
• Maintains strict patient confidentiality pursuant to the FDA, GCP and ICH guidelines regarding research subjects.
• Contributes to a positive work environment and performs other duties as assigned or directed in order to enhance the overall team efforts of the organization.
• Completes assigned goals.

Requirements, Preferences and Experience

Education

Preferred: Associate Degree preferred

Minimum: Minimum of 2 years regulatory experience or 5 years experience as an Administrative Assistant. Proficient in use of Microsoft Office Suite, Internet Explorer, and general office equipment. Excellent written, verbal and organizational skills. Knowledge of FDA, GCP and ICH guidelines regarding clinical research.

Experience

Minimum: Minimum of 2 years direct experience in clinical research regulatory position or 5 years experience as an Administrative Assistant.

About Baptist Memorial Health Care

At Baptist, we owe our success to our colleagues, who have both technical expertise and a compassionate attitude. Every day they carry out Christ's three-fold ministry-healing, preaching and teaching. And, we reward their efforts with compensation and benefits packages that are highly competitive in the Mid-South health care community. For two consecutive years, Baptist has won a Best in Benefits award for offering the best benefit plans compared with their peer groups. Winners are chosen based on plan designs, premiums and the results of a Benefits Benchmarking Survey.

At Baptist, We Offer:

• Competitive salaries
• Paid vacation/time off
• Continuing education opportunities
• Generous retirement plan
• Health insurance, including dental and vision
• Sick leave
• Service awards
• Free parking
• Short-term disability
• Life insurance
• Health care and dependent care spending accounts
• Education assistance/continuing education
• Employee referral program

Job Summary:
Position: 1882 - Coordinator-Regulatory II
Facility: BMHCC Corporate Office
Department: BCRI Baptist Clinical Research
Category: Administrative Non Clinical Support
Type: Non Clinical
Work Type: Full Time
Work Schedule: Days
Location: US:TN:Memphis
Located in the Memphis metro area