Regulatory Specialist

PRIMARY DUTIES AND RESPONSIBILITIES

1. Facilitates the protocol approval process and maintains regulatory compliance for all

Research projects submitted to the Central Research Office (CRO). Prepares and

maintains regulatory documents and Institutional Review Board (IRB) submissions for all

client managed protocols. Plans, prepares and manages timelines for assigned

regulatory documentation including initial submissions, meeting requests, protocol

assistance and annual reports. Initiates, collects and coordinates information to prepare

regulatory documentation packages for review and Monitors and tracks status of pending

protocols for Research Oversight Committee (ROC) and IRB review and approval

• Prepares and submits initial protocol, informed consent form, FDA Form 1572 and the investigator brochure and any revisions throughout the course of the study
• Prepares and submits all study related recruitment materials to the sponsor & IRB for review and approval
• Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor
• Ensures safety letters (i.e. MedWatch reports) are reviewed by the Principal Investigator and submitted to the IRB
• Prepares and submits interim status reports and final summaries to the sponsor and IRB describing study activity
• Oversees preparation of all closed study files for archiving in long term storage

2. Serves as contact for research projects and maintains records and corresponds with all

parties involved

3. Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory

compliance

4. Completes regulatory correspondence and composes correspondence for administrative signature as appropriate.

5. Coordinates and prepares mail outs including maintaining/updating distribution lists. May be required to compile statistical reports.

6. Manages and maintains study postings and related updates for clinical trials

7. Maintains annual update of physician and research staff curriculum vitae, professional

licenses, human subjects protection training and financial disclosure forms.

8. Supports the IRB Manager with IRB related activities and projects.

9. Coordinates and participates in monitoring visits and internal /external audits of

regulatory files.

10. Keeps abreast of federal and local regulations as it relates to clinical research and makes

recommendations to modify process and procedures as necessary.

ADDITIONAL DUTIES AND RESPONSIBILITIES

1. Coordinates and maintains office supplies and performs other related office support

functions as necessary.

2. Reads, date stamps and routes all incoming mail.

PROFESSIONAL DEVELOPMENT AND LEADERSHIP

1. Able to continually sharpen skills with respect to their job responsibilities.

2. This position will involve frequent interaction with physicians, sponsors, Contract

Research Organizations and IRB’s.

ADDITIONAL DUTIES AND RESPONSIBILITIES

1. Demonstrate effective professional communication and negotiation skills

2. Facilitate and model open communication among all NSH staff involved in the conduct

of clinical research

3. Maintain confidentiality in all aspects of communication

4. Foster professional presentation of verbal and written communications

5. Assist administration and management with the review, development and implementation

of institutional policies and procedures to assist compliance with federal, state and local

laws and regulations related to clinical research

6. Maintains a helpful/professional attitude toward staff, patients, physicians and other

clients.

7. Other duties as assigned

PATIENT POPULATION

Employees must demonstrate and maintain current knowledge and skills necessary to provide

care/services appropriate to the age of the patients served in their department. The grid below

identifies the age group(s) of patients served, the nature of services provided and the skills

necessary to provide the care appropriate for the ages of the patients served by this position.