Stony Brook University Assistant Administrative Director, CCTO in Stony Brook, New York
Assistant Administrative Director, CCTO
The position of Assistant Administrative Director (AAD) is responsible for directing and managing as well as providing oversight for the clinical research operations of the Cancer Clinical Trials Office (CCTO). The AAD guides and directs the study coordinators/research nurse coordinators and data managers assigned to the various Disease Teams within Stony Brook Cancer Center’s CCTO by establishing and implementing operational standards and monitoring progress. The position requires a strong emphasis on data quality and accountability. Additionally, by working with the Quality Assurance/Educator, the AAD guides and supports education, orientation and continuing professional education relative to the conduct of cancer clinical trials. The AAD is also responsible for analyzing current outcome data and identifying items for further study to increase staff and patient benefits. The AAD will work with others in a cooperative manner, exercising diplomacy, respectfulness, tactfulness and professionalism at all times.
Duties of an Assistant Administrative Direction may include the following but are not limited to:
Directs and manages study/research nurse coordinators and data coordinators within the CCTO. Meets with staff on a regular basis to assess programs and/or implement policy or procedural progress. Communicates with Disease Team physicians regularly to remain abreast of all clinical issues. Makes recommendations in conjunction with CCTO Administrative Director and QA/Educator to establish new and revise policy and procedures. Develops compliance reporting tools demonstrated in weekly status reports to the Compliance Department Director. Coordinates external audit visits and in conjunction with other management members, responds to audit reports by developing corrective action plans and subsequently implementing and documenting progress of plans.
Interprets University, federal and state policies and standards, and in response, develops and implements standard operating procedures by which the data management team will function.
Verifies eligibility for all enrollments prior to registration with sponsor and subsequently verifies source documentation for all case report form (CRF) fields to include proper consent document. Identifies unusual or inconsistent documentation for study areas, such as inconsistencies in protocols and informed consent forms based on general knowledge of biological principles and scientific methods. Follows up on corrections, revisions, amendments as appropriate to ensure accuracy and completeness of study records.
Actively participates in the strategic planning process of the CCTO.
Develops and executes educational in-services pertinent to the performance of clinical research to ensure high level and consistency of services provided to Stony Brook Cancer Center Disease Teams. Develops and implements a departmental specific formal orientation for new employees. Identifies sources for required regulatory information (e.g., EPA, FDA, IRB) for new guidelines/trends as outlined in the Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines.
Responsible for recruiting, hiring, and developing the evaluation process for study/research nurse coordinator and data manager performance reviews. Supervises and trains new and existing staff members. In conjunction with Disease Team Leaders, completes employee performance evaluations. Proceeds with appropriate action.
Represents the Clinicial Trials Office on University/Hospital committees and task forces as assigned. Serves as a liaison to promote Clinical Research at the state and federal levels.
Required: Bachelor's degree in Business Administration, Nursing, Health Sciences and/or related field. In lieu of a degree, a combination of education and at least 7 years of directly related experience will be considered.Five years of progressive management experience, preferably in an academic healthcare setting. Experience and knowledge with clinical trials and research. A demonstrated understanding of organizational dynamics, excellent interpersonal skills and team-building skills. Proven ability in planning and Human Resource Management. Proficiency with computers, software (Office, Windows, Excel).
Preferred: Previous experience in Cancer Clinical Trials Administration or Management. Certified Clinical Research Coordinator or similar professional certification. Experience with clinical trial-related databases.
Special Notes: Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
All Hospital positions are subject to changes in pass days and shifts as necessary. This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
The selected candidate must successfully clear a background investigation. Prior to start date, the selected candidate must meet the following requirements: Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services (The hiring department will be responsible for any fee incurred for examination), submit (3) written references, and provide a copy of any required New York State license(s)/certificate(s). Please be advised that failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.
The best ideas in medicine start with the best people. At Stony Brook Medicine, our highest calling is to put the power of ideas to work in our patients’ lives. Stony Brook Medicine integrates and elevates all of our health-related initiatives: education, research and patient care. Stony Brook Medicine is Long Island’s premier academic medical center. With 603 beds, we serve as the region’s only tertiary care center and Level 1 Trauma Center, and are home to the Stony Brook Heart Institute, Stony Brook Cancer Center, Stony Brook Children’s Hospital, Stony Brook Neurosciences Institute, and Stony Brook Digestive Disorders Institute. We also encompass Suffolk County’s only Level 4 Regional Perinatal Center, state-designated AIDS Center, state-designated Comprehensive Psychiatric Emergency Program, state-designated Burn Center, the Christopher Pendergast ALS Center of Excellence, and Kidney Transplant Center. It is home of the nation’s first Pediatric Multiple Sclerosis Center.
Stony Brook University is an Affirmative Action/Equal Opportunity employer. We are committed to the creation of a diverse and inclusive campus climate. We encourage protected veterans, individuals with disabilities, women and minorities to apply.
This function/position has been designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
Pursuant to Executive Order 161, no State entity, as defined by the Executive Order, is permitted to ask, or mandate, in any form, that an applicant for employment provide his or her current compensation, or any prior compensation history, until such time as the applicant is extended a conditional offer of employment with compensation. If such information has been requested from you before such time, please contact the Governor’s Office of Employee Relations at(518) 474-6988or via email firstname.lastname@example.org.
IF YOU NEED A DISABILITY-RELATED ACCOMMODATION, PLEASE CALL THE UNIVERSITY HUMAN RESOURCE SERVICES DEPARTMENT AT (631) 632-6161 OR THE UNIVERSITY HOSPITAL HUMAN RESOURCES DEPARTMENT AT (631) 444-4700.
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Job Field: Administrative & Professional (non-Clinical)
Primary Location: US-NY-Stony Brook
Official Job Title: TH Senior Staff Assistant
Department/Hiring Area: Cancer Clinical Trials
Stony Brook University Hospital
Pass Days: Day Shift
Posting Start Date: Aug 30, 2018
Posting End Date: Sep 29, 2018, 10:59:00 PM
Salary: Commensurate with experience
Salary Grade: SL3
Req ID: 1802434