Sr. Compliance Monitoring Specialist

Sr. Compliance Monitoring Specialist

The Johns Hopkins Center for Indigenous Health is seeking a Sr. Compliance Monitoring Specialist. There are several Institutional Review Boards (IRBs) that we report to and interact with to conduct our work. The Sr. Compliance Monitoring Specialist is an integral member of the research team and is responsible for all interactions with the various IRBs. This individual serves as the Center's expert on IRB and regulatory requirements and will lead all IRB related activities at the Center. The Sr. Compliance Monitoring Specialist will help prepare and submit initial proposals, annual and quarterly reports, amendments to protocols, manuscripts, and abstracts to all IRBs. The Sr. Compliance Monitoring Specialist will work closely with all levels of Center and tribal constituencies and will be expected to work independently and exercise excellent judgment and discretion. This position will work with existing systems to ensure smooth IRB processes, develop new systems as needed, and oversee the IRB-related work of the Center.

Specific Duties & Responsibilities

• In cooperation with relevant staff and institutional officials, will work to interpret and apply all aspects of pertinent tribal government regulations and institutional policies pertaining to human subject's research and related matters.
• Review applications submitted to the IRBs to identify deficiencies under tribal, state and federal laws and regulations, and institutional policies that must be corrected prior to IRB review.
• Determine that appropriate protocol and application-specific documentation is submitted, e.g., requests for waiver of consent, waiver of HIPAA authorizations, formal communications from the FDA or commercial sponsors.
• Assist in the review of IRB action outcomes, including the IRB's minutes where required, and determine that regulatory, and policy issues and their outcomes are documented appropriately.
• Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist faculty and staff with regulatory documentation issues.
• Provide ongoing regulatory guidance to Center investigators and study team members.
• Lead regulatory strategic planning meetings with faculty to assist with protocol planning and addressing complex regulatory issues that may arise as part of the IRB submission and review process.
• Develop and lead educational offerings for Center faculty and staff, Fellows, Post-docs, IRB members and Chairs, and tribal stakeholders as requested.
• Independently conduct a review of select research applications (new applications, further study actions, relevant single IRB applications) and work with faculty/research staff to identify deficiencies needing correction prior to IRB approval.
• Read, understand, and write scientific protocols, informed consent forms, SOPs, etc.
• Translate scientific information.
• Frequently exchanges information using tact and confidentiality as appropriate requiring strong oral and written communication skills. Often maximizes these skills to express, both orally and in writing, the mission and vision of the Center.
• Exercises sound administrative judgement and assumes responsibility for decisions, consequences, and results having an impact on people and the quality of service within the functional area.

Additional Knowledge, Skills & Abilities

• Working knowledge of Good Clinical Practice or willingness to be trained on GCP.
• Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations, as well as the ethical considerations related to that subject.
• Ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods.
• Good analytical writing and verbal communication skills.
• Knowledge of the ethical principles and regulations relevant to human subject's research and IRB processes.
• Familiarity with Tribal IRB processes.
• Demonstrated ability to work independently, exercise sound judgment, and multi-task.
• Ability to communicate in a professional, positive, and persuasive manner.
• Ability to work as a team member, be very detail-oriented, and communicate with faculty and staff both internal and external to the institution at all levels.
• Strong administrative/coordination skills.
• Experience in high volume office and ability to meet time sensitive processing deadlines. Ability to work in a fast-paced and demanding environment and able to manage multiple tasks effectively.
• Must be proficient, or able to become proficient in all applicable software applications.

Minimum Qualifications

• Bachelor's Degree in related field.
• Five years related experience in research administration or clinical trials/medical research. Knowledge of federal human subjects research regulations (FDA,HHS) and GCP guidelines.

Preferred Qualifications

• Native language speaker.
• Ability to translate technical medical terminology and concepts into relatable language and examples.
• Knowledge of local geography and culture, prior work experience in this community.
• Prior research experience.