Administrative Manager -(Clinical Trials Manager)
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, financialauditing and other clinical research methods such as screening, interviewing, reviewing
medical records, case report forms, etc.
Substantial knowledge of contractlanguage 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:
Bachelor's degree in clinical specialty such as nursing or a closely related field.
At least four  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.