Janelle Mack Email and Phone Number

Assist investigators, sub-investigators, and other Lightship personnel in successfully implementing and conducting clinical research studies. Provide nursing care to study participants in their homes which may include, but are not limited to, protocol-defined procedures and assessments such as vital signs, physical exams, and EKGs. Serve as the primary point of contact for participants, investigators, and study personnel when coordinating and conducting general study activities.

Provides nursing care in a level one surgical trauma ICU. Preform complex assessments and interventions and provide advanced life support, treating wounds, controlling infections, and monitoring vital signs. Care for patients with multi-system organ failure and manage life sustaining and diagnostic equipment.

Collaborate with manager to review protocols/synopses for feasibility in the context of the decentralized clinical trial model for delivery of nursing services. Participate and provide mobile research nurse services to qualified study participants at home. Apply clinical research and nursing practices to develop solutions to complex problems. Refine and/or develop standard operating procedures (SOPs) in collaboration with Quality and Regulatory departments. 50-70% travel.

Provided independent and co-monitoring visits on pediatric oncology, adult cardiac, and adult lung transplant trials in the US and Canada. Visits conducted onsite and remotely in accordance with SOPs, ICH and GCP, and FDA guidelines. 70-80% travel.