The Clinical Research Associate Supervisor will function under the supervision of the Cancer Research Program Manager, overseeing diverse activities related to clinical trials studies. Responsible for providing leadership and day-to-day supervision of the Clinical Research Associates and Clinical Research Assistants in the Cancer Center.
Personnel management of 5-6 CRC's in multple therapeutic areas of adult cancer therapy; motivating and mentoring staff. Continually re-prioritizing work in a fast-paced and ever-changing environment.
Consequently, the employee must be competent in the interpretation of a patient's self-report or behavior, and this information must be interpreted with an understanding of the cognitive, physical, emotional/psychosocial and chronological maturation process. The treatment of patients should be individualized and should reflect an understanding of the developmental needs and range of treatment needs for each patient.
The job duties listed are essential functions of the position. However, other duties may be assigned, and may also be considered essential functions of the position.
Responsible for all aspect of clinical data management, including collection of source documents, completion of case reports forms, and tracking/reporting of serious adverse events. Captures/ enters data into clinical trial database as necessary.
Reviews clinical data, generate study data reports, and assist with the completion of clinical study reports.
Completes quality control audits to verify the accuracy, completeness, and confidentiality of research data.
Facilitates site audit visits and provides written account to management.
Establishes procedures and systems (i.e., computerized database) for research coordination and data management. Develops and improves research information systems.
Liaise with sponsors when applicable and coordinate study drug shipments and accountability. Set-up monitoring visits and addresses monitoring reports.
Serves as a resource liaison for investigators and other researchers involved in the day to day management of patients on clinical trials.
Implements quality assurance principals for the controls for accuracy, completeness, and confidentiality of research data.
Provides support to individual physician investigators to ensure compliance with treatment plans and follow-up studies, and assesses outcomes. Conducts follow-up for assessment of off-treatment patients.
Responsible for the day-to-day supervision of all Clinical Research Associates and Clinical Research Assistants within the Cancer Center and all related Human Resource issues.
Develop a rapport with potential study sponsors to facilitate the selection of the site for clinical studies and pre-study evaluation visits; might be involved in the completion of study budget feasibility.
Attend investigators meetings/ various study related training and meetings.
Assists in the assessment and evaluation of potential research studies and patients for eligibility and feasibility. Collects and maintains complete records and statistics on each research study patient.
Establishes and promotes positive working relationships within the department, throughout the hospital and between other institutions involved in clinical cancer research.
Involved in the completion of projects of varying complexity in conjunction with other team members or management.
Interacts favorably with people by phone and in person, and works effectively as part of a team.
Performs detailed, accurate computer entry functions. Good data entry skills required.
Highly motivated and able to take initiative.
Involved in on-going quality review of documents generated for completeness and accuracy.
Problem solver, resourceful, and proactive with excellent follow-up skills.
Demonstrated interpersonal skills and the ability to adapt to the needs of staff in order to provide effective leadership.
Demonstrated ability to coach, counsel and mentor staff.
BS or MS Degree
5 years experience in clinical research
Previous oncology research experience, prefer experience with National Cancer Institute trials but not a requirement
Previous supervisory experience including training, mentoring, developing staff
PC computer, Internet, telephone, fax machine, calculator, photocopy machine.
Advanced level proficiency in Microsoft Access, Excel, Word, Internet Explorer, and Outlook are required.
Excellent verbal and written communication skills.
Highly organized and attentive to details.
Communicates well with patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information.
Assists with the development and implementation of policies and standard operating procedures.
Able to manage multiple research projects, prioritize projects, and supervise staff simultaneously.
SOCRA certification required or ACRP certification required.
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