Sr Research Regulatory Coordinator 1

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.
Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:

Instill Trust and Value Differences
Patient and Community Focus and Collaborate

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), CV’s, 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 department’s 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.

MINIMUM QUALIFICATIONS:

BASIC KNOWLEDGE:
Bachelor’s degree in health-related or scientific field is required; Master’s 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.

Pay Range:

EEO Statement:

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

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