Reporting to the Director, Breast Oncology Cohort Operation & Data Management, the Associate Director, Cohort Studies Operations is responsible for the overall management and oversight of the Cohort Studies managers. The Associate Director oversees all cohort studies and aids in associated program activities, has direct supervisory responsibilities for the clinical research managers and regulatory coordinators and indirect ongoing oversight of program managers and coordinators, clinical research coordinators (CRCs) and research data specialists (RDS). This position collaborates and regularly meets with the Cohort Studies Managers, Program Managers, and other Research Managers that routinely interface with breast oncology to promote excellence and streamlined collaboration in non-therapeutic clinical research and program development across the department. The Associate Director ensures compliance with all regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by DFCI and the Dana-Farber Harvard Cancer Center (DF/HCC) consortium.
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.
ResponsibilitiesCohort Studies and Clinical Program Operations – Overall Management
Meet regularly with clinical research managers and program managers to review ongoing research and program activities: day to day study execution adherence [consenting, biospecimen, survey, and clinical data collection] and to serve as the point person to resolve real time issues / conflicts that may prevent study execution and/or compliance. Responsible for ensuring clinical research managers and program managers provide the required oversight, review, and regular monitoring of CRC / RDS workload distribution.Work with key stakeholders to identify, collaborate and resolve issues interfering with abilities to meet operational goals; specifically regarding protocol / amendment activation activities.Report defined progress and metrics to Director on a regular basis; identify barriers and solutions to meet goals.Cohort Studies and Clinical Program Operations - Best Practices
Lead and implement standardized best practices and process improvements across cohort studies and clinical programs where needed in collaboration with Director.Serve as point person to ensure operational workflows are followed: consenting and preparation for sample, survey and clinical data collection.Cohort Studies and Clinical Program Operations - Staff Hiring, Supervision, Training and Development
Hire, on-board, train and provide supervision to all Clinical Research Managers, Senior Clinical Research Coordinators, and Regulatory Coordinators when applicable.Assist Clinical Research Managers with hiring, training and supervision of their research operations staff when needed.Report quarterly analysis on significant trends in hiring, training, and supervision; including action plans to address.SUPERVISORY RESPONSIBILITIES:
Directly supervises clinical research managers and regulatory coordinators. Qualifications Bachelor’s degree in a field relevant to research compliance required; Master’s degree or higher preferred.7 years of progressively responsible experience with conducting and managing trials and other research studies required; 5 years with master’s degree. Experience in an academic institution is highly preferred, especially working in collaborative efforts with upper administrators, faculty, and research staff as well as research support personnel. Must have expertise in research ethics and the responsible conduct of research. Previous experience with working with registry/cohort and/or biobanking studies a plus.KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Strong organizational, project management and supervisory skills, with the demonstrated ability to develop and manage complex projects in a matrix environment.Team-oriented leader who is results driven and able to motivate others. Superior written and verbal communication skills.Strong attention to detail.Entrepreneurial attitude and skills, including a willingness to take risks.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 characteristics protected by law.
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