Remote Fda Jobs in Boston, MA (NOW HIRING)

This position's work location is fully remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
The Office for Human Research Studies (OHRS) manages Scientific Review and Institutional Review Board (IRB) review for the institutions that comprise the Harvard Cancer Consortium (HCC): Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Boston Children’s Hospital, Dana-Farber Cancer Institute and Massachusetts General Hospital. There are five Scientific Review Committees (SRC) and seven IRBs that oversee cancer related human subject research for HCC. The OHRS manages more than 3,000 new and ongoing HCC research protocols with more than 14,000 submissions received for SRC / IRB review per year. OHRS is also responsible for HIPAA review of research.
The Associate Director for Education and sIRB represents OHRS at DFCI and HCC meetings and ensures decisions are compliant with the human subject protection regulations. The Associate Director is expected to work independently to identify high level operational and substantive issues and devise appropriate management plans, communicating as necessary with senior officials at all the Harvard clinical institutions that operate under the umbrella of the HCC.
The Associate Director is a member of the OHRS Senior Staff and reports to the Director, HRPP. The Associate Director supervises Senior IRB Analysts and protocol-focused IRB Analysts. The Associate Director also supervises the OHRS Meeting Coordinators. The Associate Director ensures staff compliance with FDA and HHS regulations for IRBs.
The Associate Director Education and sIRB is responsible for the oversight of single IRB responsibilities and educational training including training of OHRS staff and IRB members on institutional review board policies; institutional policy and operations; and representation at meetings of the institutions that comprise the HCC, and Harvard catalyst. The Associate Director also oversees the process of single IRB and leading communication efforts between the DFCI IRB and external IRBs.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
 

Primary Duties and Responsibilities:

• Oversees the process of review and approval of clinical and non-clinical research.
• Serves as an IRB member on the seven IRB committees. Reviews and oversees IRB determinations to ensure compliance with the human subject regulations and HIPAA.
• May also serve as the senior OHRS representative at specific IRB meetings and be tasked with assisting with the IRB reviews and ensuring regulatory compliance. May also be responsible for supervising the work of IRB analysts on the committee and the review of the IRB minutes.
• Creates and implements ongoing education programs for IRB members.
• Creates and implements ongoing education programs for OHRS staff, including leading the Certified IRB Professionals Certificate training program in OHRS.
• Acts as lead liaison on implementing reliance agreements amongst external IRBs for the federally mandated single IRB review requirements, including creating reliance agreements, collecting local context information, and communicating outcomes to external institutions.
• Consults with the clinical trials offices of the five Harvard institutions that comprise the HCC consortium (e.g., BIDMC CCTO, MGH CCPO and DFCI CTO).
• May attend, on behalf of OHRS, meetings with the DFCI Office of the General Counsel, DFCI Research Compliance, DFCI Office of Research Integrity for guidance and advice on legal issues impacting the IRB review of clinical research
• When appropriate, ensures prompt reporting of Non-Compliance, Unanticipated Problems and Suspensions of Research to the appropriate oversight agency, e.g., FDA, OHRP.
• Implements and manages compliance with HIPAA regulations as they relate to research.
• Aids in maintaining the DFCI IRB Policies and Procedures and training protocol-focused analysts on regulatory and operational changes.
• Represent OHRS at outside conferences and meetings (e.g., PRIMR, AAHRPP).
• Assists with projects as directed by the OHRS Directors and Senior Director
• Updates content on the OHRS website including guidance documents for research teams.
• Ensures quality and consistency among the seven different IRB panels.
• Identifies office-improvement needs and supervises office-improvement working groups.
• Ensures operational efficiency among the seven IRB committees as well as internally within the OHRS

Knowledge, Skills and Abilities:

• Demonstrated expertise in application of federal regulations to clinical research.
• Knowledge of HIPAA regulations as they relate to research.
• Knowledge of Federal, state, and local regulatory information regarding the protection of human subjects in biomedical research.
• Strong written and verbal communication skills necessary to allow productive communication between OHRS, HCC Leadership, Investigators and other research personnel.
• Problem solving, decision-making and analytical skills necessary to identify problems and proposed solutions and the ability to implement solutions.
• Ability to work independently and cooperatively.
• Flexibility and motivation to work on special projects relating to the mission of OHRS as directed by the Directors and Senior Director.

Minimum Job Qualifications:

• Bachelor’s degree required.
• 5 years of experience in a cancer center and/or working with an academic IRB or research office required.
• 3 years of staff management experience required.

License/Certification/Registration Required:

• CIP certification preferred.

Supervisory Responsibilities:

• Directly supervises IRB staff (Senior IRB Analysts and protocol-focused IRB Analysts.)

Patient Contact:

None

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.  

EEO Poster.

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$106,400.00 - $118,000.00