Location: Providence,RI, USA
Summary:
Under the general supervision of the Clinical Trials Director and Research Manager and in accordance with established policies and procedures supervises the staff and day-to-day activities of the Dermatology Clinical Trials Unit at the Providence VA and/or other nearby sites.
Responsibilities:
Supervises the research staff and day-to-day activities of the Dermatology Clinical Trials Unit at the Providence VA and/or other nearby sites.
Maintains study participant volume in order to achieve clinical trial competitive enrollment targets and clinical trial revenue metrics.
Participates with the principal investigator in the development design and data management of multiple clinical research studies. Participates in developing protocols intervention plans and subject recruitment. Provides for the tabulation and analysis of data results for publication and reporting.
Participates in interview and selection of the clinical trials research staff. Conducts annual evaluation of research staff. 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.
Organizes and implements the protocol of the project provides direct services as outlined by the project criteria. Provides direction for the clinical research project. May function as needed in the role of senior clinical research assistant/coordinator.
Ensures accurate and complete collection of research data and development of associated database and reports. Analyzes resultant research data and participates in interpretation of same with investigator. May assist in the preparation and presentation of research papers.
Participates with research investigators and departmental research administrative staff in development and negotiation of project budgets. Regularly monitors monthly budget reports identifying and resolving variances ensuring accuracy and conformance to budget. Invoice and provide financial oversight of clinical trial studies and activities. Within organization and department guidelines authorizes purchases related to research project. May order capital equipment as approved within budget.
Assess and secure appropriate resources for clinical trial patient and employee needs.
Interface with outpatient departments to access services needed to conduct clinical trials (Pharmacy Clinical Research Center Pathology Imaging Cardiovascular Facilities HVAC Purchasing Office of Research Administration Audiology Employee Health Ambulatory Nursing Biomedical Engineering Central Supply etc.)
Provide clear and timely conversation with pharmaceutical sponsors to adhere to terms and conditions of engaging in clinical research.
Maintain Brown Dermatologys clinical trials webpage.
Determine monthly expense and salary allocations related to clinical trials.
Oversee freezer usage and the remote temperature monitoring system to ensure the integrity of the investigational drugs and specimens in adherence to the clinical trial protocols.
Continually assess and anticipate research needs to meet the demands of the clinical trials (i.e. ensuring equipment supplies and resources are ordered available and accessible).
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.
Reviews current literature for update approaches to research being conducted. May assign review of specific literature to research staff requiring preparation and submission of summary analysis.
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.
May require outside travel to evaluate sites or for other project-related reasons.
Maintains and enhances professional expertise through educational opportunities and review of pertinent literature.
Other information:
BASIC KNOWLEDGE:
Bachelors Degree or equivalent through relevant work experience is required. Masters Degree preferred.
Proven leadership capabilities.
Excellent communication organizational problem-solving and computer skills required.
May require valid drivers license where project requires travel off-site.
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 7 full-time equivalent personnel.
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