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Director, Research Compliance

Woods Hole, MA 02543

Posted: 01/26/2023 Employment Type: Direct Hire/Perm Job Category: Administrative Job Number: 541765 Is job remote?: No Country: United States

Job Description


 

Director, Research Compliance
 
Must Have:

 

Bachelor’s degree from an accredited university in a related field.

Five (5) years progressively responsible experience in a regulatory, legal, and/or compliance-related capacity in healthcare, research, business, and/or university environment. 

Must be a US Citizen and able to obtain SC

 

Nice to Have:

 

Master’s degree in a related field or Juris Doctor degree from an accredited university.

 

 

 

 

Essential Functions

 

 

Oversees the Institution’s compliance risk assessment process and manages the preparation of a comprehensive risk-based compliance plan, consisting of short- and long-term items as well as planning for potentially high-risk research items.

Participates in the review and revision of policies and procedures to ensure they are adequate to mitigate risk and to prevent illegal, unethical, or improper conduct of research.

Oversee compliance high-risk areas to ensure compliance risks are appropriately mitigated. Assist the high-risk responsible parties in the development of a risk mitigation compliance plan including daily, monitoring and oversight controls and specialized training for those involved in the high-risk area.

Monitor developments and changes in statutes and court rulings, rules and regulations that impact research compliance areas and obtain up-to-date information.

Responsible for export control oversight, including the development of training, education and assessment tools, and the implementation of policies and procedures to promote the Oceanographic’s ongoing compliance with export control laws. Work closely with Institutional Security on developing and maintaining an institutional export control policy.

Serves as the official point of contact with export control regulatory agencies; works with the team to conduct export control reviews and restricted party screenings; assists in the determination of export license requirements and need for Technology Control Plans; ensures the submission of export license, commodity jurisdiction, advisory opinion, and classification requests to federal agencies; recommends USCIS Form I-129 certification status for H-1B Visa applicants

Coordinates with pertinent departments and personnel on export control issues.

Provides oversight of the institutional annual conflict of interest disclosure process. Work with the DDVPSE on the project specific financial disclosure process and serve on the institution’s Conflict of Interest Committee.

Coordinates the evaluation of outside activity requests and/or disclosures of employees and prepare management plans as requested for non-research personnel. Report information to executive management, as appropriate.

Together with the DDVPSE, coordinate the activities of the IRB, IACUC and IBC.

Oversees the development and maintenance of general research compliance training for employees and monitoring of completion percentages.

Develop and deliver research compliance specific training to new employees, and follow up training to departments and groups when requested

Serve as compliance delegate on multiple institution committees such as the Advisory Committee on Ethics, Conflicts and Security (ACECS) and others as designated or requested.

Responsible for the overall direction, coordination, and evaluation of the department 

Plans, assigns, and directs workloads of assigned staff

Highly organized, detail oriented, and also prefer to have Six Sigma training or a similar system

Non-Essential Functions:

 

Performs other duties as deemed necessary to serve the Development Office and/or the Institution's needs.

Performs other duties as assigned.

Education & Experience

Required Education & Experience 

 

Bachelor’s degree from an accredited university in a related field.

Five (5) years progressively responsible experience in a regulatory, legal, and/or compliance-related capacity in healthcare, research, business, and/or university environment. Experience in dealing with federal and state regulations and assisting in the design of appropriate compliance monitoring procedures to meet those requirements. 

Must be a US Citizen and able to obtain SC

 

 

Preferred Education & Experience 

 

Master’s degree in a related field or Juris Doctor degree from an accredited university.

Ability to ensure adherence to all policies and procedures of the Institution. Effectively interpret and apply organizational policies, procedures, and systems. Work requires proven supervisory, customer service, and written and verbal communication skills. Ability to plan, organize, coordinate, and supervise work of employees as necessary to ensure desired results are achieved. May require telephone and personal contact with all levels of internal and external personnel and organizations. Ability to monitor and maintain budget.
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