The Assistant Director, Research Compliance Office will work under the oversight of Dana-Farber Cancer Institute’s (DFCI’s, Institute’s) Research Compliance Officer (RCO) to grow and manage the activities of a high quality, robust, and sustainable research compliance program. Investigates and resolves research compliance allegations and issues, drafts and maintains research compliance policies and procedures, provides expert regulatory guidance and advice on research compliance and regulatory matters, conducts and coordinates focused training and education for faculty and staff, and provides subject matter expertise and guidance to the Research Compliance Committee. Participates in the monitoring of various DFCI departmental operations as they relate to research compliance risk areas, regulatory enforcement activity, and legal updates affecting DFCI’s research operations. Manages large, complex projects and issues with a high degree of autonomy. This position reports directly to the Institute’s Research Compliance Officer (RCO). 

PRIMARY DUTIES AND RESPONSIBILITIES:

• Receives, investigates, documents, and tracks research compliance complaints from workforce members, patients and/or family members. 
• Coordinates with stakeholders, including HR, to develop and implement timely responses to issue reported including corrective action plans (including ensuring consistent application of disciplinary action standards).
• Coordinates with the RCO and stakeholders to report to state and federal authorities, as required (including, for instance, research sponsors such as the NIH, FDA, Office for Human Research Protections (OHRP), and/or Office for Laboratory Animal Welfare (OLAW).
• Assists the Research Integrity Officer (ORI) and other team members with research misconduct investigations.
• With guidance from the RCO, develops, implements, maintains, and oversees training and education programs for research compliance issues for the Institute, including, for example, new employee orientation, annual online training, and department-specific training; Initiate and promote additional activities within the Institute to foster research compliance awareness
• Supports the RCO to work with Communications and other departments, as necessary, spearheading efforts to effectively communicate research compliance messaging and education.

• Conducts an annual research compliance risk assessment and develop work plan to address identified risks, including conducting audit and monitoring activities.
• Cooperates with federal and state entities in any research compliance program audits, inquiries or investigations.
• With direction from the RCO, develops, implements, maintains and oversees research compliance policies and procedures of the Institute.
• Stays current with relevant federal and state research compliance laws and regulations and modify the research compliance program accordingly to remain compliant, as well as consistent with industry best practices.
• Enhances professional growth and development by participating in educational programs, distributing and reading current literature and conducting and participating in in-service meetings and workshops.
• With the RCO, serves as an Institute resource and expert on the laws, regulations and internal policies pertaining to research compliance.
• Works with Institute departments and offices (e.g., faculty activities, research administration, grants and contracts, clinical trials, human and animal subject protection, privacy, technology transfer, etc.) to advance research compliance objectives in a sustainable way.
• Collaborates with counterparts at other Dana-Farber/Harvard Cancer Center (DF/HCC) sites, Harvard Medical School-affiliated institutions, and outside research sites.
• Develops and maintains relationships and networks with peer/affiliate research compliance officers, researches compliance groups, and committees (e.g., Partners HealthCare System and Alliance of Dedicated Cancer Center Research Compliance Officers and related groups).
• Advises and/or participates in DF/HCC Institutional Review Boards (IRBs).

• Provides support to research compliance committees or groups as directed by the RCO.
• Performs other functions relating to policies and procedures regarding research compliance as assigned.

MINIMUM JOB QUALIFICATIONS:

• Bachelor’s degree in the field of research compliance.
• 4 years of professional experience in healthcare and regulatory research compliance; academic medical center experience.
• Relevant post-graduate education (JD or master’s degree in a scientific field).

PREFERRED QUALIFICATIONS

• Experience at an academic, research, or hospital setting (such as grants management, clinical trial management, or research administration).
• Background in science or medicine is an advantage.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Exemplary commitment to research compliance and ethical conduct.
• Knowledge of and experience with federal and state research compliance laws and regulations.
• Demonstrated commitment to:
• Working in a team-based environment,
• Handling patient and highly reputable researcher interactions/communication with extreme care, patience and consideration, and
• Creating an environment with open channels of communication within the Institute with workforce members, patients, and others.
• Excellent organization, attention to detail, technical and analytical skills. 
• Demonstrable discretion, diplomacy, and good judgment. 
• Possess strong communication and presentation skills, including clear and concise written and spoken expression of ideas and ability to adapt communications appropriately to the audience.
• Strong project management skills.
• Advanced technical skillset in MS Office (Word, Excel, PowerPoint);.

SUPERVISORY RESPONSIBILITIES: None

PATIENT CONTACT: Limited patient interaction; no direct clinical contact.

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 groups as protected by law.