Clinical Research Operation Manager Jobs (NOW HIRING)

Please note that though this position's location and responsibilities will be at the Joslin Diabetes Center, employment & application will be through Associated Physicians of Harvard Medical Faculty Physicians (APHMFP).  Please use the link below to complete your application.

Please click on this link to apply to the Clinical Research Center Manager position via HMFP.

The Joslin Clinic Research Center Manageris a practitioner who provides care as well as supervision, management, and leadership to support the daily operations and future direction of the Joslin Clinical Research Center (CRC). This individual oversees adherence to SOPs, Good Clinical Practice and FDA regulations. They are also responsible for assuring the alignment/compliance of Clinical Research Center policies and procedures with the Joslin Diabetes Center, BIDMC and Beth Israel Lahey (BILH) objectives and policies. They develop and maintain a team-oriented environment that supports the research operation, performance improvement and staff development.

As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) as a condition of employment.

Performs Clinical Research Assessments and Procedures

• As needed, provide age specific care to pediatric and adult patients with or without diabetes mellitus in a collaborative practice, by using competencies in history taking, physical examination, assessment and interpretation of laboratory and related diagnostic tools for purposes of screening and safety assessments of participants participating in clinical research studies.
• Makes judgments relative to physical assessment and therapeutic management independently, using physician consultation where appropriate.
• Performs clinical research procedures within their scope of training and practice.

Leadership

• Maintains a leadership role regarding the day to day operation, fiscal responsibilities and strategic planning.
• Serves as a key resource to all members of the research teams.
• Represents the organization in external research related activities. Builds relationships with academic and clinical department administrators.
• Provides guidance to clinical investigators and clinical research staff on individual study projects focusing on feasibility and initiation issues and best practices.
• Supports division leadership in the future direction of the CRC.
• Participates in a leadership role in all administrative aspects of research programs, including budget development, coordination of staff, licensing, reporting and quality assurance.
• Promotes effective communication related to problem solving and support for team members.

Policies and Procedures 

• Develops, designs, implements and monitors clinical research policies and procedures for research protocols in collaboration with the individual research teams.
• Implements and monitors adherence to research policies and procedures, using systems that will improve the overall operation and effectiveness of the organization.
• Assists in the integration/updating of research policies and procedures for external legal and administrative regulations, other regulatory agencies, research sponsors, along with the organization.
• Communicates changes regarding policy and procedures, practices and systems to the Clinical Research teams.
• Develops, documents, implements and monitors written policies and procedures reflective of the CRC mission and objectives.
• Partners with BIDMC to assure any hospital policies, including pharmacy policies are adhered to and communicated to Joslin research teams.
• Functions on committees as needed.

Performance Improvement and Education 

• Collaborates in the development, implementation and expansion of learning opportunities and skill development for all staff.
• Develops and implements effective educational programs and training modules designed to assist the researchers in the progression from novice to expert in the practice of research and enhances their knowledge and guides them towards the achievement of excellence.
• Provides, education, training and direction to the clinical research teams to ensure safe and competent protocol execution.
• Contributes to educational and professional development of staff, and colleagues in an environment of mutual respect and understanding.
• Collaborates with the research staff at all levels, interdisciplinary team members, executive officers and other stakeholders in the development, implementation and evaluation of research programs and services to meet identified needs.
• Interacts with and contributes to the professional development of peers and others.
• Evaluates own performance based on professional practice standards, relevant studies, regulations and organizational criteria identifying areas of strength as well as areas for professional/practice development.
• Coordinates and maintains the required training and skills for the research staff.
• Evaluates staff competency by direct observation, peer review, orientation and employee feedback.

Safety and Regulation

• Serves as a liaison with the Committee on Human Studies (CHS) and the Safety and Compliance Office to ensure compliance with Federal and organizational rules and regulations relating to human subject research.
• Directs, coordinates and monitors the activity/utilization of research protocols performed on the CRC.
• Identifies research operation needs, helps manage equipment and supplies and monitors equipment maintenance.
• Assesses the environment and makes recommendations to ensure optimal patient comfort, safety and compliance with various external legal and administrative regulatory bodies.
• Promotes and monitors regulatory agency standards and customer service expectations for the research practice.

• N.P. or P.A. degree from an accredited school
• Preferred past experience in diabetes clinical care or clinical research
• Licensure in the State of Massachusetts
• Ability to communicate and interact with individuals at all levels of the organization, including those in senior leadership roles
• Demonstrated nursing leadership ability
• Ability to work collaboratively with others at staff, professional staff, and administrative levels
• Ability to prioritize assignments to complete work in timely manner when there are changes in workload and pressures of deadlines.
• Self-directed
• Demonstrated excellent time management, organizational and analytical skills

The base pay range reflects what Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center (HMFP) reasonably and in good faith expects to pay for this role at the time of posting and may be modified from time to time. Actual compensation within this range may be determined based on several factors, including academic appointment, work experience, specialty training, geography of work location, anticipated productivity, FTE basis and role expectations. In addition to base compensation, this role may be eligible for performance-based incentives, which may include bonuses for productivity and quality. HMFP also offers a comprehensive and generous employee benefits program to eligible employees, including health, dental, vision, life and disability insurance, as well as retirement plan(s) with employer contributions.