Associate Director, Clinical Trials Operation

Overview

Reporting to the Senior Director, Clinical Trials Office, the Associate Director, Clinical Trials Operations is responsible for the overall management and oversight of the assigned Clinical Research Disease group managers. The Associate Director oversees all clinical trial operations activities, has direct supervisory responsibilities for the Clinical Research Managers, and indirect ongoing oversight of Assistant Clinical Research Managers (ACRMs), Clinical Research Coordinators (CRCs) and Research Data Specialists (RDS) within those assigned groups.

Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups. This position is expected to meet with Disease Center Clinical Research Directors on a regular basis to solicit feedback, discuss initiatives and review study team performance.

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.

Responsibilities

Clinical Trials Operations - Overall Management

* Meet regularly with CRMs and ACRMs to review ongoing clinical trials activities: day to day protocol conduct execution adherence and to serve as the point person to resolve real time issues / conflicts that may prevent protocol conduct execution and or compliance.
* Responsible for the ensuring CRMs and ACRMs 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.
* Partner with CTO Sr. Director and other key stakeholders to collaborate with lead Industry Partners to enhance productive relationships to support common goal outcomes.
* Report defined KPI progress to CTO Sr. Director on a regular basis; identify barriers and solutions to meet goals.

Clinical Trials Operations - Compliance

* Oversee, track and report on assigned Disease Groups compliance KPIs; overall protocol compliance, safety reports, SAE, Deviation reporting, kit / sample collection adherence, etc.
* Oversee, track and report on monitoring and audit findings, reports, and corrective actions (CAPA) progress / compliance.
* Ensure assigned disease groups are implementing the most up to date DFCI, DF/HCC and all relevant regulatory authority SOPs and regulations.

Clinical Trials Operations - Best Practices

* Lead and implement standardized best practices and process improvements across assigned research disease groups.
* Point contact for all protocol sponsors to resolve clinical trial conduct issue and to ensure efficient clinical trial conduct and management across assigned disease groups.
* Serve as point person to ensure operational workflows are followed; protocol scheduling, patient reimbursements, Y2 / Materials Management (kit coordination and specimen collection), and applicable pharmacy activities.

Clinical Trials Operations - Staff Hiring, Supervision, Training and Development

* Hire, train and provide supervision to all Clinical Research Managers and Assistant Clinical Research Managers when applicable.
* Assist Clinical Research Managers and Assistant Clinical Research Managers with hiring, training and supervision of their clinical research operations staff when needed.
* Report quarterly analysis on significant trends in hiring, training, and supervision; including action plans to address.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

* Extensive knowledge of federal, state, and local regulations concerning relevant research compliance areas.
* Ability to interpret legislation, regulations, policies, procedures, and ethical principles in research compliance.
* Ability to translate regulations into operational policies and procedures.
* Knowledge of the broader research environment, including emerging regulatory trends, best practices at other institutions, conflict of interest, responsible conduct of research, and other issues.
* Demonstrated expertise in developing and delivering regulatory and compliance training and standard operating procedures.
* Excellent communication skills and an ability to work with diverse constituencies within an academic community.
* Ability to handle multiple activities simultaneously, manage a diverse group of staff within a challenging reporting structure, and to effectively prioritize and carry out strategic initiatives.
* Team-oriented leader who is results driven and able to motivate others.
* Proficient in computer applications (e.g., Microsoft Office suites, including Excel and PowerPoint)

SUPERVISORY RESPONSIBILITIES:

Directly supervises Clinical Research Managers within the Disease Centers.

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 clinical trials required; 5 years with master's degree preferred.
* 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.

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.

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