Details
Posted: 19-Feb-25
Location: Linthicum Heights, Maryland
Categories:
Operations
Internal Number: REF37845A
Job Description
The Senior Associate Counsel, Clinical Trials and Research, provides legal support for clinical trial and research activities across the University of Maryland Medical System (UMMS). This role involves refining processes to streamline time-to-activation for clinical trials, standardizing contracting approach and forms, negotiating and drafting research contracts, ensuring regulatory compliance, and fostering collaboration between UMMS, its flagship academic institution, the University of Maryland Medical Center (UMMC), and other UMMS member organizations involved in clinical trials and research activities. The position requires partnership with University of Maryland - Baltimore, the School of Medicine, Faculty Physicians and assorted compliance and regulatory affairs teams across organizations to ensure adherence to applicable laws, regulations, and organizational policies.
Principal Responsibilities and Tasks
The following statements are intended to describe the general nature and level of work being performed by individuals assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.
- Draft, negotiate, and review agreements for clinical trials, research collaborations, data use agreements and related activities.
- Develop and refine legal and operational processes to optimize time-to-activation for clinical trials and research matters.
- Provide legal support for initiatives with UMMS's academic health system partners, the faculty and School of Medicine, focusing on contracts, document concordance, efficiency of process, compliance, and strategic partnerships.
- Serve as a direct legal advisor to academic and research leaders on research and investigational-related matters including and beyond clinical trials such as expanded access agreements and pre-clinical studies.
- Collaborate with the compliance department to ensure adherence to human subjects protection and clinical research laws, including HIPAA, FDA regulations, and Good Clinical Practice (GCP).
- Address legal and ethical issues in clinical research, including informed consent, conflict of interest, and intellectual property matters.
- Manage relationships and legal processes between UMMS member organizations and the flagship academic institution to harmonize clinical trial operations.
- Support initiatives to align research activities with organizational goals and regulatory standards and to integrate research administration across the system.
- Draft and implement policies and procedures related to clinical research contracting and compliance.
- Provide training to faculty, staff, and research administrators on legal and regulatory requirements.
- Engage with external sponsors, CROs (Contract Research Organizations), community providers, collaborating research entities, and regulatory bodies to negotiate agreements and ensure compliance.
- Lead legal reviews for joint research ventures, cooperative agreements, and grants.
Scope of Position
- This position is a unique opportunity to partner with System leads on the establishment of a unified research office for all of UMMS and to foster the good work underway to standardize and optimize research processes and growth appropriate for a research-oriented and an innovative academic health system. This senior counsel position will also support the System's efforts around the protection of data in research and related commercial activity with academic and commercial partners.
- The responsibilities of this position require the individual to research, evaluate, interpret and resolve problems. Further, the individual guides and advises corporate officers and managers to ensure they are fully aware of the legal ramifications of their actions and decisions and advises them as to the proper and controlling legal requirements or precedents.
- This position impacts corporate programs and established policy through participation as legal advisor on committees developing/implementing policies, programs and projects.
- The individual in this position must remain current with legal issues affecting the System and the health care industry. The individual must ensure that, in the event of litigation, the appropriate documents, contracts and agreements are properly prepared and executed and that competent and knowledgeable staff is involved in the process.
- The individual acts within corporate policies and guidelines and according to the tenets of behavior of the legal profession.
Company Description
The University of Maryland Medical System (UMMS) is an academic private health system, focused on delivering compassionate, high quality care and putting discovery and innovation into practice at the bedside. Partnering with the University of Maryland School of Medicine, University of Maryland School of Nursing and University of Maryland, Baltimore who educate the state's future health care professionals, UMMS is an integrated network of care, delivering 25 percent of all hospital care in urban, suburban and rural communities across the state of Maryland. UMMS puts academic medicine within reach through primary and specialty care delivered at 11 hospitals, including the flagship University of Maryland Medical Center, the System's anchor institution in downtown Baltimore, as well as through a network of University of Maryland Urgent Care centers and more than 150 other locations in 13 counties. For more information, visit www.umms.org.
Qualifications
Education and Experience
- Juris Doctor Degree from an accredited law school.
- Admission to the bar of a least one state, preferably Maryland.
- 10+ years of progressively responsible experience as a practicing health care attorney with contract experience in both government, non-profit, and commercially-sponsored research.
Knowledge, Skills and Abilities
- Current knowledge of health care-related legal issues including HIPAA Privacy and Security compliance, the Common Rule and other statutes, rules and regulations governing the protection of human subjects, clinical research, and investigational drug and device activities (i.e. NIH, OHRP and FDA rules and regulations), as well as a general awareness of other important laws impacting the operation of an academic health system, including but not limited to the State of Maryland and federal reimbursements for hospitals, Medicare, Medicaid, The Joint Commission, Stark and anti-kickback legislation, False Claims Act, Medicare/Medicaid enrollment survey/certification, corporate governance, tax-exempt issues and state regulations relating to the delivery of health care.
- Demonstrated healthcare law experience in the areas of clinical research, hospital/healthcare business operations and contracting; hospital/physician contracting and health care privacy.
- Strong legal research and analytical skills, ability to multi-task and prioritize workload, ability to work independently, collaboratively and effectively in a fast-paced environment.
- Proven organizational skills; ability to advise about legal requirements in specific contexts and find ways to meet them while pursuing operational objectives.
- Highly effective verbal and written communication skills with an ability to provide sound, clear legal advice to all levels within the organization, including senior business executives, medical staff, management, residents, executive staff, other management personnel at all levels, regulators, the media, and the community; judgment and self-confidence but also respect for others, regardless of position, and willingness to work as a team member.
- Ability to work closely with, facilitate interactions within, and influence large cross-functional teams (including representatives from other areas of the OGC, regulatory and compliance professionals, and operations managers/directors).
- Notable business acumen dealing with risk management and organizational savvy.
- Experience in leading and managing attorneys and a demonstrated ability to be an effective leader within an established legal department.
- Experience effectively developing and implementing strategy, in partnership with outside counsel as appropriate, to address complex regulatory inquiries.
- Executive leadership and ability to see and handle more than the legal issues of a project; strong, pragmatic business acumen with the ability to recognize the business consequences of legal advice, a strategic and innovative thinker who can develop and articulate a clear understanding of the organization strategy from all perspectives and find creative solutions to complex legal problems
- Personal credibility and the ability to articulate legal positions and strategies concisely and quickly, in a manner that is useful and easily understood by the business partner.
- Proven track record of strong negotiation, communication, organizational, and people management skills and the ability to influence and build relationships without direct authority.
- Positive attitude and proactive, nimble, creative and flexible in thought, and able to adapt to a changing environment.
- Team player who can develop strong working relationships and work collaboratively with internal business partners and other members of the senior legal team. Ability to lead by example including a willingness to "roll up sleeves" and undertake day-to-day legal work.
