Sr Research Regulatory Coordinator

1 month ago

Providence, United States Lifespan Full time

Summary:
The Sr. Research Regulatory Coordinator is responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Sr. Research Regulatory Coordinator  performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr. Research Regulatory Coordinator  will provide support in managing the clinical trials within the department instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries.  The Sr. Research Regulatory Coordinator  shall work closely with department leadership.

Responsibilities:
The Sr. Research Regulatory Coordinator  is responsible for all duties listed under the Regulatory Coordinator position such as:
Develops protocols with the Principle Investigator and provides recommendations on research plan Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees study team business office contract research organizations and sponsors. Prepare and maintain study specific regulatory binder(s) and documents Serves as the regulatory subject matter expert through all phases of a clinical study including regulatory documents and/or processes related to clinical trials conduct Initiates and leads special projects to include process improvement and regulatory training Ensures proper regulatory compliance in accordance with sponsoring agency requirements Liaises with sponsors investigators and team members providing trial information and updates as required in written oral and meeting format adhering to appropriate timelines
Additionally the Sr. Research Regulatory Coordinator position will be responsible for the following: Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications.  Manages the preparation of annual reports to the FDA as necessary. Manages and updates clinical trial/ study information located on the clinicaltrials.gov website as needed. Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI) CVs MLs HSP and GCP training.  Coordinate audits and site visits with monitors concerning compliance of regulatory documents.  Responsible for preparing for institutional federal and sponsor audits and assist with the drafting of audit responses.  Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the departments mentorship program.  Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems.   Compile regulatory-related metrics for use by department leadership. Performs other duties as assigned.

Other information:
BASIC KNOWLEDGE:

Bachelors degree in health-related or scientific field is required; Masters degree preferred.
SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire.
Sound knowledge of all federal local and state guidelines pertaining to Clinical Research. 
Must be an independent person who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Must demonstrate strong leadership and organizational skills.  
Must possess the following skills: 

  • Detail-oriented and excellent organizational skills
  • Strong-self-starter
  • Interpersonal skills
  • Strong problem-solving skills 
  • Team-oriented
  • Excellent oral and written communication skills
  • Proficient in Microsoft office and in various database applications
Comprehensive knowledge of FDA guidelines
Ability to foster smooth communications and teamwork among clinical research faculty fellows and staff as well as external organizations necessary
EXPERIENCE:
3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience.
Past experience in federal state and/or local programmatic regulations compliance.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:
This position is a sedentary position.  One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required. 
INDEPENDENT ACTION:
This position requires a quick-thinker who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies including but not limited to study sponsors local and federal agencies.  The candidate should be able to answer protocol regulatory inquiries from researchers and physicians as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently.  He/she should be able answer inquiries related to regulatory issues and if not known communicate with the correct person to determine the answer. 
SUPERVISORY RESPONSIBILITY:   
One to three regulatory staff members.

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Lifespan is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union

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