Open to opportunities

Lexie Reissaus

@lexiereissaus

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Experienced clinical research manager specializing in trial operations, regulatory compliance, and team leadership.

United States

Message

What I'm looking for

I seek a leadership role in clinical research where I can manage trial operations, streamline processes, mentor teams, ensure compliance, and contribute to publications within a collaborative, growth-oriented organization.

I am a clinical research manager who leads trial operations, team training, and regulatory compliance with a focus on quality and efficiency.

I implement and oversee industry-sponsored and investigator-initiated studies, develop protocols and informed consents, manage IRB submissions, and negotiate study budgets and contracts to support successful study startup and execution.

I also manage library services, perform literature searches, prepare bibliographies, train clinical staff in literature searching, and support manuscript and abstract preparation to strengthen research output.

Previously I served as a clinical team lead and project associate, building CTMS and TMF systems, conducting monitoring and audits, mentoring staff, and implementing process improvements; I hold a B.S. in Biology and am completing an M.S. in Clinical Project Management (expected Aug. 2027).

Experience

Work history, roles, and key accomplishments

Current

Librarian

Current

Indiana Hand to Shoulder Center

Jan 2022 - Present (3 years 8 months)

Manage library operations and expenditures while providing medical literature searches, reference services, user training, and patient education to support clinical staff and research activities.

Library Management Reference Services User Training Patient Education

Current

Clinical Research Manager

Current

Indiana Hand to Shoulder Center

Feb 2020 - Present (5 years 7 months)

Oversee and train entry-level site coordinators and manage operations for industry-sponsored clinical trials, including protocol development, IRB submissions, and CTA negotiation to ensure regulatory compliance and study readiness.

Clinical Research IRB Submission CTMS EHR Regulatory Compliance GCP)

Clinical Research Coordinator

Indiana Hand to Shoulder Center

Jan 2018 - Feb 2020 (2 years 1 month)

Supported protocol development, IRB submissions, and regulatory documentation while recruiting and screening study subjects and coordinating training for clinical staff to ensure protocol adherence.

IRB Submission GCP)Regulatory Staff Training

Clinical Team Lead

SCRI Development Innovations

Jul 2015 - Dec 2017 (2 years 5 months)

Acted as project lead overseeing clinical, budgetary, and regulatory activities, implemented CTMS and monitoring tools, and mentored team leads to drive study delivery and performance metrics.

Project Management Clinical Operations CTMS Monitoring Vendor Management GCP)

Clinical Project Associate

SCRI Development Innovations

Feb 2014 - Jul 2015 (1 year 5 months)

Maintained Trial Master File and regulatory documentation, supported site qualification and monitoring activities, and assisted PMs/CRAs to ensure site compliance with GCP.

Trial Master File Document Management GCP)Monitoring CTMS Regulatory Affairs