Research Study Manager - Clinical Trials

Position Details

Position Information

Recruitment/Posting Title	Research Study Manager - Clinical Trials
Job Category	Staff & Executive - Research (Laboratory/Non-Laboratory)
Department	RWJ-Medicine-Cardiology 5-Meb
Overview	New Jersey’s academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University–New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers. Our clinical and academic facilities are located throughout the state—at Rutgers University–New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark’s University Hospital in Newark, and other affiliates. Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives.
Posting Summary	Rutgers, The State University of New Jersey, is seeking a Research Study Manager – Clinical Trials for the department of Medicine at the Robert Wood Johnson Medical School. The Clinical Trials Research Study Manager, under the direct supervision of the Research Director of the Division, will assist in activities to support and grow the Clinical Research – driven by innovation and digital transformation – in the Division. These activities include, but may not be limited to supporting lab testing, including setup, processing and shipping, ordering of supplies, developing source documents, data entry, record maintenance and archiving, study visit tracking, assisting with budget preparation and registration of study subjects. IRB submission and maintaining compliance with IRB, HIPAA, and FERPA guidelines, and engaging scientifically in grant applications. Among the key duties of this position are the following: Work closely with supervising research director and principal investigator(s) to develop protocols for clinical research proposals, organize research activities and maintain effective communication between project staff, external collaborators, funding agencies, and regulatory entities. Oversees research activities to achieve study timelines and quality execution. Providing proactive leadership and oversee all aspects of research operations. Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results. Support the development of publishable materials relating to the clinical research (Manuscript submission, abstracts, study presentations). Developing both short-term and long-term plans for growth and expansion of existing services; as well as, for the introduction of new programs. Assure compliance of general and study specific regulatory related processes with ICH, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies. Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees and Institutional Review Board, maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CVs, licenses, site laboratory certifications).
Position Status	Full Time
Hours Per Week
Daily Work Shift
Work Arrangement	This position requires a fully on-site work arrangement.
FLSA	Exempt
Grade	28S
Position Salary
Annual Minimum Salary	89548.000
Annual Mid Range Salary	113278.000
Annual Maximum Salary	137008.000
Standard Hours	37.50
Union Description	Non-Union
Payroll Designation	PeopleSoft
Benefits	Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to http://uhr.rutgers.edu/benefits/benefits-overview .
Seniority Unit
Terms of Appointment	Staff - 12 month
Position Pension Eligibility	ABP

Qualifications

Minimum Education and Experience	Bachelor Degree in a relevant science or a related field (e.g. biological sciences, biomedical engineering, public health, business administration). Minimum of three (3) years of research related experience and working in a team across multiple functional areas. Equivalent education, experience, and/or training may be substituted for the degree requirements (i.e. fellowships, internships, advanced research experience, publications etc.) may be considered.
Certifications/Licenses
Required Knowledge, Skills, and Abilities	Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel and PowerPoint. Must be capable of independent decision-making, and multitasking.  The ideal candidate will be detail oriented, have excellent organizational skills, be proficient in computer applications, possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful. To be successful, the candidate must have excellent organization, communication and interpersonal skills.
Preferred Qualifications	Demonstrated experience leading clinical research operations. Master Degree in a relevant science or a related field.  Understanding of the software program Oncology Collaborative Research Environment (Oncore). Experience with electronic medical record management systems (Epic/SCM).
Equipment Utilized
Physical Demands and Work Environment	Physical Demands: Standing, sitting, walking, talking or hearing. No special vision requirements. Work Environment: Office/Clinical environment. Moderate Noise.
Special Conditions	May be required to travel.

Posting Details

Posting Number	24ST0265
Posting Open Date
Special Instructions to Applicants
Regional Campus	Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus	Downtown New Brunswick
City	New Brunswick
State	NJ
Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

Under Policy 60.1.35 Immunization Policy for Rutgers Employees and Prospective Employees , Rutgers University requires all prospective employees to provide proof that they are vaccinated against COVID-19 prior to commencement of employment, unless the University has granted the individual a medical or religious exemption. Rutgers University may require certain prospective employees to receive an updated (bivalent) vaccine dose. Under Policy 100.3.1 Immunization Policy for Covered Individuals , if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.

Affirmative Action/Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement