The work location for this position is full remote with occasional time onsite, however the selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT)
The Associate Research Compliance Officer (ARCO) will work under the oversight of the 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, with a focus on clinical research. The ARCO 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 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 RCO.
Responsibilities
Works collaboratively with clinical investigators and research staff members to address concerns, investigate complaints and to communicate findings that can lead to improved clinical trial performance and/or compliance.
Acts as a key contact and subject matter expert for queries related to internal standard operating procedures, Good Clinical Practice guidelines, and current regulations.
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 and/or Office for Human Research Protections (OHRP).
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.
Works with Communications and other departments, as necessary, spearheading efforts to effectively communicate research compliance messaging and education.
Conducts an annual clinical 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.
As necessary, 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).
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, research compliance groups, and committees (e.g., Partners HealthCare System and Alliance of Dedicated Cancer Center Research Compliance Officers and related groups).
Assists the RCO and Research Integrity Officer and other team members with research misconduct, conflict of interest and research security investigations.
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.
Qualifications
Bachelor’s degree required.
4 years of professional experience in healthcare and regulatory research compliance.
Relevant post-graduate education (JD or master’s degree in a scientific or clinical field) or equivalent professional experience.
Preferred Qualifications
Experience in an academic, research, or hospital setting (such as grants management, clinical trial management, or research administration).
Strong knowledge of federal, state, and sponsor regulations regarding the conduct of clinical trials, including investigator-initiated trials, the informed consent process, trial congruency, and protection of human subjects.
Prior monitoring or auditing experience in clinical research, particularly in an academic medical setting.
Experience developing and delivering compliance training.
Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS), PRIM&R or the Society of Clinical Research Associates (SOCRA).
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 equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse 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 groups as protected by law.
