Senior CRA / Project Leader

Eleison Pharmaceuticals is seeking a Senior Clinical Research Associate / Project Leader to join its team in the greater Philadelphia /DelawareValley area.  This is an excellent opportunity for a self-motivated team player to join a young pharmaceutical company at an early stage and provide significant contribution to the growth and development of the clinical development department and processes.

Eleison’s mission is to acquire, develop, and commercialize clinical stage drug candidates for orphan oncology indications, providing new hope for patients with rare life-threatening diseases. The Company has two programs in late-stage development and is in discussions to acquire other promising candidates for rare cancers. Eleison was founded in 2009 and is headquartered inPrinceton,NJ.

Summary:

The successful candidate will immediately share in the management of a small phase II multicenter oncology study while also performing all aspects of site monitoring responsibilities for the trial according to ICH guidelines and GCP, including Site Qualification, Initiation, Interim Monitoring, and Close-out Visits.  In addition (s)he will contribute to the development of the clinical research department and infrastructure, including SOP and process development.  The successful candidate will also be involved in the selection, training and management of future clinical research staff.

Therapeutic areas:

Oncology, hematology, rare diseases

Job Summary:

• Project management activities as assigned
• Site administration, management and monitoring responsibility for assigned clinical studies/sites according to ICH - GCP
• Manage project(s) under guidance (depending on experience) of senior management
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Prepare and deliver presentations at Investigator Meetings / Initiation Visits
• Assist medical monitor with pharmacovigilance activities for designated trials
• Participate in the development of protocols, case report forms, study manuals, study plans and other clinical trial documentation as assigned
• Contribute to clinical study reports as assigned
• Act as contact for manufacturers, laboratories and other suppliers (vendors) as assigned
• Responsible for all aspects of study site monitoring including pre-study and initiation visits, routine monitoring and close-out of clinical sites, maintenance of study files, liaising with third party vendors; and other duties, as assigned

Required Education/Qualifications:

• University/College Life science degree or Nursing qualification
• Must be able and willing to travel
• A full understanding of the Serious Adverse Event (SAE) reporting process
• A detailed knowledge of ICH-GCP

Required Experience:

• A minimum of 4 years of clinical research monitoring experience including Site Qualification, Initiation, Interim Monitoring, and Close-out Visits is required. 
• In house experience preferred
• Oncology experience essential
• Project management experience preferred

Qualified candidates should send their resume and salary history to matthew.parris@eleison-pharma.com

Eleison is a top-tier employer seeking exceptional candidates.