College / University, Hospital, Public and Private
Excellence, Teamwork, Leadership and Innovation. These are the values that define UConn Health, and we are looking for team members who share these same values. Our top rated organization is looking to add a full time Administrative Manager (Clinical Trials Manager) located in Farmington.
At UConn Health, Office of Sponsored Program Services, Clinical and Translational Research Services Unit with responsibilities that cover both the UConn Health and University of Connecticut campuses, this position is responsible for the overall planning and direction of the unit, negotiation of Confidential Data Agreements, Clinical Trial Agreements at UConn Health and complex and sensitive agreements across all campuses.
Responsible for ensuring that all terms are acceptable to UConn Health and/or the University of Connecticut and are in compliance with all State and Federal regulations and institutional policies and guidelines.
Competitive salary/comp structures
Industry leading, affordable access to medical, dental, vision, life and retirement benefits
Tuition waivers and reimbursements for self and qualified dependents
Easy access to I-84, Rte 9 and surrounding Greater Hartford communities
Organizational culture focused on diversity and inclusion, innovation and patient experience
State of the art, award winning campus environment...and more
Receives general direction from the Director of Research Administration and Faculty Services and the Director, Sponsored Program Services.
Supervises the staff of the Clinical Trials Research [CTR] unit of Sponsored Program Services.
Duties & Responsibilities:
Plans unit workflow; coordinates assignment and work reviews, scheduling, training, staff orientation, and recruitment, conducts performance
evaluation and coaching; works closely with HR on recruitment, performance improvement plans and other HR issues.
Assesses Medicare eligibility for payments for clinical trials under the Medicare National Care Decision and supervises Medicare coverage
analysis and contract reviews which includes identification of routine care versus protocol induced care.
Oversees the budget development and budget workbook preparation and charge code identification processes.
Negotiates agreements related to Clinical Trials ensuring that the terms are acceptable to UConn Health and conform to state and federal laws and regulations and institutional policies, procedures and practices.
As assigned by the Director of Research Administration and Faculty Services, negotiates unique, complex and sensitive agreements for activities at all institutional campuses.
Works closely with senior leadership, other institutional departments and faculty to ensure complex agreements are negotiated in a timely manner while ensuring the terms are acceptable to the institution and in compliance with appropriate laws, regulations, policies and procedures.
Acts as an expert resource to Contract Managers at both UConn Health and University of Connecticut campuses in the absence of or as assigned by the Director of Research Administration and Faculty Services.
Ensures that research is conducted at the University in a manner that accounts for the resources consumed;
Provides leadership and develops strong working relationships with Principal Investigators, serves as liaison to IRB.
Communicates with operating units, agencies and external officials regarding unit policies and procedures.
Ensures financial compliance for all Clinical Trials research assigned to the University; performs ongoing and closing audits.
Prepares annual reports, data and statistics relevant to financial compliance contract and budget negotiations.
Provides supervision regarding disease processes and medical services performed as part of the clinical trial.
Researches financial compliance regulations pursuant to clinical trials/research budget development and implementation, clinical trials/research financial compliance, clinical trials/research contract negotiations.
Performs other related duties as required.
Knowledge, Skills & Abilities Requirement:
Substantial knowledge of Federal, State and institutional laws and regulations which govern research financial compliance; substantial knowledge of Medicare National Coverage Determination that regulates research financial compliance for clinical trials; knowledge of clinical research protocols, principles and procedures; substantial knowledge of Medicare regulations regarding clinical trials; knowledge of clinical trials budget development, contract and budget negotiation, financial auditing and other clinical research methods such as screening, interviewing, reviewing medical records, case report forms, etc.
Substantial knowledge of contract language and negotiation related to research administration including intellectual property.
Leadership skills with the ability to direct activities of others both individually and within a project team; proficient computer skills; excellent interpersonal, organizational and communication [oral and written] skills.
Ability to use electronic medical record system [EPIC]; ability to analyze and interpret data.
Qualification/Experience & Training:
Master's degree in clinical specialty such as nursing or a closely related field.
At least three  years clinical research management experience which includes managing research studies with internal and external review agencies, and regulatory oversight processes.
Must be familiar with the clinical research/pharmaceutical industry.
At least three (3) years experience with contract negotiation in either research administration or clinical trial agreements.
SCHEDULE: 40 hour work week, Monday through Friday, 8am-5pm.
Why UConn Health
UConn Health is a vibrant, integrated academic medical center that is entering an era of unprecedented growth in all three areas of its mission: academics, research, and clinical care. A commitment to human health and well-being has been of utmost importance to UConn Health since the founding of the University of Connecticut schools of Medicine and Dental Medicine in 1961. Based on a strong foundation of groundbreaking research, first-rate education, and quality clinical care, we have expanded our medical missions over the decades. In just over 50 years, UConn Health has evolved to encompass more research endeavors, to provide more ways to access our superior care, and to innovate both practical medicine and our methods of educating the practitioners of tomorrow.
To apply for this Administrative Manager - (Clinical Trials Manager), 2018-1166 position, you may use the Candidate Self-Service (CSS) online application. After submitting your application, you may also have the opportunity to upload a cover letter, a resume, and references. You MUST have these documents available at the time of application. To complete an application, please click on Apply for this position . The UConn Health is an affirmative action employer, in addition to an EEO and M/F/V/PWD/PV employer. All employees are subject to adherance to the State Code of Ethics which may be found at www.ethics.state.ct.us.
Internal Number: 2018-1166
About UConn Health / University of Connecticut
The University of Connecticut (UConn) is a Land Grant and Sea Grant college and member of the Space Grant Consortium, and is ranked among the top 25 public universities in the nation according to the 2018 U.S. News and World Report America's Best Colleges. In support of an ambitious state investment in economic development, higher education and research, the Office of the Vice President for Research seeks highly motivated, skilled, and engaged individuals to work within an increasingly diverse and complex research environment.
The University of Connecticut is committed to building and supporting a multicultural and diverse community of students, faculty and staff. The diversity of students, faculty and staff continues to increase, as does the number of honors students, valedictorians and salutatorians who consistently make UConn their top choice. More than 100 research centers and institutes serve the University's teaching, research, diversity, and outreach missions, leading to UConn's ranking as one of the nation's top research universities. UConn's faculty and staff are the critical link to fostering and expanding our vibrant, multicultural and diverse University commu...nity. As an Affirmative Action/Equal Employment Opportunity employer, UConn encourages applications from women, veterans, people with disabilities and members of traditionally underrepresented populations.