CLINICAL RESEARCH ASSOCIATE Galleon Pharmaceuticals
Galleon Pharmaceuticals, located in suburban Philadelphia, is a clinical-stage biopharmaceutical company that focuses on building a portfolio of novel medicines for breathing control conditions, such as sleep apnea, ventilator weaning, drug-induced respiratory depression, COPD, obesity-hypoventilation syndrome, and several other less common diseases. Founded in 2005, Galleon is headquartered in Horsham, PA, USA.
This is a CRA/CPM position responsible for performance of CRA and CPM duties for the conduct of early clinical trials. Clinical studies will be conducted in U.S., EU and possibly other major economic areas. The CRA/PM will be responsible to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA/CPM makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement.
CRA/CPM duties will include writing clinical protocol by translating scientific/clinical objectives into effective solutions. CRA/CPM responsibile for organizing, communicating and evaluating team objectives for clinical studies. Study teams will consist of internal and external stakeholders with diverse functional expertise and expert knowledge. Essential duties will include planning and managing clinical trials in order to achieve quality results. CRA/CPM will be responsible for management of external contract organizations , institutional review board approvals, clinical study agreements, monitoring reports, and trial master file maintencance. CRA/CPM will participate in and facilitate analysis, summary and reporting of clinical data for regulatory review.
CRA/CPM may supervise and assess the performance of internal/external study team members and train team members on clinical operations. In addition, must maintain good relations with investigators, medical research staff and outside consultants. CRA/CPM will serve as liaison between Galleon, investigative sites and clinical research organizations, ensuring appropriate resources are available for a project and resolving project conflicts.
The candidate will posess a bio-medical related scientific degree, or equivalent experience. The candidate should have expert knowledge of ICH-GCP (more than 5 years), experience in early clinical research (Phase 1 and/or 2), and experience in U.S./EU conduct of regulated research.
Additionally the candidate must have:
Professional use of the English language, both written and oral
Ability to work independently with good judgment and accountabilty
Understanding of cross functional drug development teams
Ability to recognize potential obstacles and work to resolve them within set timelines
Availability to travel internationally > 50%
Position will be contract with the potential for full-time hire. Galleon Pharmaceuticals offers the opportunity for career development through exposure to all phases of the development process and the unique opportunity to work closely with distinguished leaders.
||Horsham, PA |