Clinical Research Unit Clinical Director, Office of the CSO

Position: Clinical Research Unit Clinical Director, Office of the CSO

Location: Boston, MA

Schedule: 40 hours per week

POSITION SUMMARY:

The Clinical Research Unit Clinical Director (Clinical Director) is an experienced clinician who oversees clinical research activities occurring in the BMC Clinical Research Unit (CRU); ideal candidates have experience running clinical research units. The Clinical Director is responsible for oversight of clinical operations for all studies occurring in the CRU, and is accountable for study performance, including implementing central standards, procedures, and policies; ensuring the highest levels of safety, compliance and customer service; oversight of the clinical feasibility review of protocols; management of clinical personnel and resources; monitoring and reporting on evaluation metrics; and preparing executive summaries.

The Clinical Director will report to the Medical Director, with a dotted line to the Chief of Nursing, and will co-lead the CRU in partnership with the CRU Director of Business Operations, with guidance from the Senior Director of the Center for Clinical Research Advancement. The Clinical Director will interface with research faculty, and clinical staff to ensure strong coordination and open communications, focusing on the sharing of best practices and lessons learned. This position will also focus on developing consensus on common approaches to change management, continuous improvement, and prioritizing research faculty and research needs. Will ensure CRU clinical capacity, efficient, timely workflows and high customer satisfaction of the services provided. This position will have the responsibility to monitor protocol performance toward the goal of conducting clinical research at the highest standard.

JOB RESPONSIBILITIES:

LEADERSHIP

• Provide day-to-day clinical leadership, medical and clinical expertise, guidance and support to the clinical research unit.
• Ensure all processes and procedures in the unit are aligned with those required of the hospital for compliance and safety.
• Collaborate with the nursing quality team, Nursing Director, and other hospital leaders. Facilitates necessary research education and professional development for nurses assigned to the unit.
• Promotes research focused professional development of clinical nurses working within the unit. Partners closely with CRU Director of Business Operations to serve the values and key performance indicators of the CRU.

CLINICAL OBLIGATIONS

• Working onsite when patients are in the unit.
• Support clinical nurses staffed within the clinic on various duties and responsibilities.

STAFFING OVERSIGHT

• Responsible for oversight and conduct of nursing and clinical research support staff within the clinic.
• Clinical research administrative support staff will report to the CRU Director of Business Operations with a dotted line reporting structure to the Clinical Director

CLINICAL OPERATIONS

• Utilizes best practices and Standard Operating Procedures to ensure consistent quality research and effective clinical research practices are conducted.
• Identifies and ensures IT processes/systems are utilized to maximize departmental and institutional efficiencies.
• Serves as an expert resource to researchers for clinical trial/clinical research processes, assisting with the designing of study-specific workflows, and exhibits sound problem-solving skills. Applies expert knowledge of regulatory requirements (ICH, FDA, GCP, institutional and departmental) to clinical research operations.
• Acts as the primary liaison between faculty, clinical management (infusion, pharmacy, laboratory), and the Center for Clinical Research Advancement (CCRA) when resolving conflicts or areas in need of clinical improvement.
• Provides guidance and oversight to PIs that have " PI-initiated studies" and is available for consultation with PI-initiated protocol design.

STRATEGIC PLANNING

• Assists management in institutional and departmental new business development (increased utilization of clinical research space, recruitment of pharmaceutical sponsored studies).
• Reviews sponsor protocols for feasibility and practicality for the institution and clinical research space when applicable.
• Serve as a liaison and expert resource for internal and external customers. Promote customer service through the development and implementation of programs and quality standards.
• Collaborates with other research administration departments and participates in institutional initiatives to enhance overall clinical research operations (including but not limited to Compliance Office).
• Perform quarterly reviews of all clinical research space to assess resource utilization. Organize a regular cadence for a Clinical Research Forum (presentations of research utilizing the clinical research space).

PROFESSIONAL DEVELOPMENT

• Provide input and actively participate in education initiatives for the department and the institution.
• Understands, adheres to and models Core Standards as defined organizationally and specifically within the clinical research unit.
• Provides support to the management team in the selection, development, motivation, evaluation and discipline of personnel.
• Stays abreast of regulatory changes/requirements impacting clinical research environments.

PROCESS IMPROVEMENT and QUALITY ASSURANCE

• Identify clinical service areas, plan approaches for improvement activities, design new processes with specifications and expectations against which success can be measured, systematically measure collected data, assess performance over time, improve and redesign processes based on the evaluation, and reassess continuously.
• Partner with CRU Director of Business Operations to implement and ensure efficient processes for activities performed in the clinical research space. Monitor effectiveness, quality standards and fiscal integrity.
• Participates in audit debriefings, reviews all audit/monitoring visit reports (internal and external), and works with the staff to develop, implement, and monitor corrective action plans; communicates these plans with the Chief Scientific Officer and Executive Director of Research Operations to determine best methods for disseminating communications regarding these corrective action plans with faculty and clinical staff.

OTHER IMPORTANT FUNCTIONS

• Displays professional, ethical and cultural competence in all interactions with others; provides guidance and holds team members accountable as needed.
• Supports study team members on a range of communication and teamwork best practices to promote effective and compliant study conduct; communicates/influences team to maximize team cohesiveness and effectiveness.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

• Master's degree in one, or more, of the following fields of study: Physician Assistant (PA), or Nurse Practitioner (NP) required; MD preferred. Would also consider candidates with an RN who have extensive clinical research experience.

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:

• Must be licensed as licensed independent provider (LIP) in the State of Massachusetts, in good standing. Would also considered registered nurses, licensed and in good standing, in the state of Massachusetts.
• Credentialed in chemotherapy administration preferred, but not required (Chemotherapy Provider Card through Oncology Nursing Society preferred, but not required)

EXPERIENCE:

• Three-five (3-5) years of clinical patient care management experience in a complex health care delivery system or organization
• Minimum of two (2) years clinical research experience and a successful track record of conducting clinical research in an academic medical center.
• Prior experience running a clinical research unit strongly preferred, but not required

KNOWLEDGE AND SKILLS:

• Demonstrated organization, leadership, and management skills, including change leadership that enables self and others to align to, plan for, lead through, and embrace changes.
• Strategic thinking and entrepreneurial spirit that anticipates the impact of technological, social, and economic trends on the institution and the role of the research enterprise in a major academic medical center.
• Effective interpersonal and communication skills with the ability to effectively lead, manage teams and engage resources.
• Record of accomplishment working with research faculty and institutional administration.
• Excellent problem-solving skills, including creativity, resourcefulness, timeliness, and technical knowledge related to analyzing and resolving financial, compliance, and/or institutional challenges impacting clinical research.

JOB BENEFITS:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

ABOUT THE DEPARTMENT:

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn't dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to Talentacquisition@bmc.org or call 617-638-8582 to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans