Summary:

Under the general supervision of the Assistant Clinical Manager (ACM) in collaboration with the Operations Manager and in accordance with established policies and procedures supervises activities of subordinate professional and support staff assigned to one or more clinical research projects within the Brown University Health Oncology Clinical Research Office (LOCR). Assist with selection orientation scheduling and work assignments. Evaluates performance of subordinate research staff. Ensures implementation of approved research program adherence to research protocols and development and maintenance of study records. 

Responsibilities:

Supervises non-nursing research staff including the clinical research professionals and non clinical support staff for all clinical trials in assigned disease group(s). Participates in interview and selection of staff. Conducts annual evaluation of subordinate staff members. Provides for training and orientation to clinical research project(s). Coordinates work schedule monitors adherence to procedures/protocols to ensure optimal patient participation rates accurate data collection etc.

Assumes primary responsibility for the implementation of Brown University Health policies and procedures for research and administrative functions within the assigned area as needed.

Organizes and implements the division of labor on assigned protocols between non-nursing research staff within the assigned disease team. Assist with review and preparation of new clinical trials before activation to ensure the team is adequately prepared to run protocols. Provides direct services as needed with assigned disease group(s). Ensures accurate and complete collection of research data points. Provides direction for assigned clinical research projects. Function as needed in direct patient care and coordination.

Participates with research investigators and clinical trial sponsors in ongoing meetings and monitoring visits. Functions as resource person during audits or on-site visits by the pharmaceutical companies and other related professional groups seeking information related to the research project. Regularly reviews monitoring reports to identify opportunities for process improvement and assist with reconciliation of patient records and sponsor databases as needed. Assists with review if deviations including root cause analyses and creating and implementing corrective action plans.

Coordinates monthly LOCR disease team meetings to ensure team is aware of upcoming trials data locks monitoring visits amendments to protocols etc.

Contacts individuals both internal and external to the hospital to provide professional consultation within area of expertise to exchange information and create streamlined workflows for collaboration with other departments.

Maintains quality assurance safety environmental and infection control in accordance with established hospital department policies and objectives. Coordinates and/or conducts annual training in these areas.

Maintains and enhances professional expertise through educational opportunities and review of pertinent literature.

Other information:

BASIC KNOWLEDGE:

Bachelor's degree in relevant discipline required. Master's degree is preferred.

EXPERIENCE:

Five years progressively more responsible related clinical research experience including demonstrated supervisory skills and effective interpersonal/communication skills.

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

While most duties are performed in an office environment incumbent is exposed to patient care environment. Any risk of exposure to contagious or noxious elements is minimized by adherence to safety procedures and protocols.

INDEPENDENT ACTION:

Incumbent functions independently within a broad scope of department policies and practices; generally refers specific problems to supervisor only where clarification of department policies and procedures may be required.

SUPERVISORY RESPONSIBILITY:

Provides direct supervision for up to 10 full-time equivalent personnel assigned to the program.

Brown University Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union

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