Senior Counsel - Clinical Trials and Research

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.

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.

1. Draft, negotiate, and review agreements for clinical trials, research collaborations, data use agreements and related activities.
2. Develop and refine legal and operational processes to optimize time-to-activation for clinical trials and research matters.
3. 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.
4. 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.
5. 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).
6. Address legal and ethical issues in clinical research, including informed consent, conflict of interest, and intellectual property matters.
7. Manage relationships and legal processes between UMMS member organizations and the flagship academic institution to harmonize clinical trial operations.
8. Support initiatives to align research activities with organizational goals and regulatory standards and to integrate research administration across the system.
9. Draft and implement policies and procedures related to clinical research contracting and compliance.
10. Provide training to faculty, staff, and research administrators on legal and regulatory requirements.
11. Engage with external sponsors, CROs (Contract Research Organizations), community providers, collaborating research entities, and regulatory bodies to negotiate agreements and ensure compliance.
12. Lead legal reviews for joint research ventures, cooperative agreements, and grants.

Scope of Position

1. 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.
2. 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