Job description
Summary:Reporting to the Principal Investigator(s) and department leadership and in accordance with established policies and procedures the program coordinator is responsible for the operation of research programs including recruitment implementation programs processes and outcome evaluation of the program.
Responsibilities:
Facilitating all IRB submissions for the Department of Neurosurgery (new projects amendments continuing reviews / progress reports AE reports etc.)
Organizing and facilitating monitoring visits with study sponsors as needed for the Clinical Trials Program
Weekly completion of research billing review for enrolled trial participants
Weekly organization of a Clinical Trials Program team meeting to review weekly enrollment goals schedules and areas of progress & improvement
Leading Clinical Trials Program day-to-day research recruitment efforts including weekly screening of the operating room schedule for potential study candidates and updating the Clinical Trials Program shared calendar
General assistance to program administrators and managers with miscellaneous administrative tasks especially those related to implementation of new projects and overseeing study activities day-to-day
Delegation of "lead CRA" tasks to other team members of the Clinical Trials Program
Maintaining regulatory records and representing the investigative team at IRB meetings as needed
General quality assurance to ensure team is in line with IRB regulations study protocols and best clinical practices in human subjects research
Facilitating day-to-day communication between managers investigators corporate sponsors and research staff to effectively facilitate project organization subject recruitment and study procedures
Assisting with database design and data management as needed
Back-up for clinical research assistant duties as needed
Other information:
BASIC KNOWLEDGE:
Bachelors degree in relevant discipline is required. Masters Degree preferred
Excellent computer skills and familiarity with statistics.
May require valid drivers license where grant requires travel outside of hospital.
EXPERIENCE:
Three or more years progressively more responsible relevant experience depending on size and complexity of program(s). Experience should demonstrate leadership skills ability to effectively prepare and monitor budgets; perform statistical analyses; and prepare manuscripts for publication.
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 5 full-time equivalent personnel assigned to the program.
Lifespan 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. Lifespan 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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