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).
Reporting to the Director, the Associate Director oversees operational activities within the department and supervises IRB Analysts. Responsibilities include identifying high level operational issues and devising appropriate management plans, assisting the Director with operational priorities, goals and on-going work-flows, and coordinating operations and administrative management of protocol review related activities and processes.The Associate Director also oversees problem solving for the research community on an ad hoc basis and updates processes as needed, consistent with relevant regulations. In addition to the above responsibilities, the Associate Director of Operations will also serve as an alternative IRB member as needed and conduct expedited IRB reviews as needed.
Primary Duties and Responsibilities:
• Manages operations impacting staff workflow and work instructions for training and employee reference.
• Develops standard operating procedures related to consortium member sites and ensure internal consistency related DF/HCC operations.
• Serves as an IRB member (or alternate) on IRB panels as needed.
• Conducts expedited IRB reviews ensuring compliance with the human subject regulations and HIPAA.
• Communicates with the clinical trials offices, and other research-related offices, of the five Harvard institutions that comprise the DF/HCC consortium (e.g., BIDMC CCTO, MGH CCPO and DFCI CTO). Responsive to research community's operational needs.
• In conjunction with senior leadership, represents the OHRS at meetings of the DF/HCC, including but not limited to the RIO working group meetings.
• Liaises with study teams regarding submissions and manage issues escalated up for operational resolution (e.g., OHRS Inbox).
• Liaises with other offices within DFHCC on operation-based office needs.
• Represents OHRS at outside conferences and meetings (e.g., PRIMR, AAHRPP).
• Assists with projects as directed by the OHRS Directors and Senior Director.
• Identifies office-improvement needs on an operational basis.
• May also actively 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.
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, DF/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.
• 5 years of experience in a cancer center and/or working with an academic IRB or research office.
• 3 years of staff management experience.
License/Certification/Registration Required:
CIP certification preferred.
Supervisory Responsibilities:
Directly supervises IRB staff (Analysts, Meeting Coordinators, etc.)
Patient Contact:
None
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
