Erin Majewski Email & Phone Number

West Chester, Pennsylvania, United States

Garnett Valley

Perkasie, Pa

- Manage multiple priorities including, but not limited to: entering and filling medications, billing insurance companies, managing inventory levels, and answering and directing phone calls- Problem solve when insurance rejects a claim, or when a prescription is written unclear/incorrectly- Educate patients on aspects such as compliance, safety, and drug disposal

Pittsburgh, Pennsylvania

- Manage clinical studies at the Central Testing Lab in collaboration with NSABP- Work with the pathology administrative group, Magee lab staff and management, and the chief of pathology at Magee- Participation on study teleconferences or in-person meetings as necessary- Participation with IRB preparation and submission as needed- Assumes multiple lead roles in protocol implementation and data management- Create an official data-entry protocol- Collect study data and entry into protocol designated database- Knowledge of clinical trial standards and FDA, IRB, and hospital lab guidelines

- Responsible for the receipt, preparation, and accountability of investigational medications- Maintain compliance with over 450 clinical research protocols and their corresponding documentation o Departments: Oncology, Psychology, Neurology, Pulmonary, Cardiology, Pediatrics, etc. - Communicate and collaborate with clinical research associates, study nurses, and coordinators- Manage drug accountability through shipments, cycle counts, drug inventory logs, patient returns, and IVRS/IXRS/IWRS/IRT systems- Organize study drugs and materials for visiting CRAs- Review incoming protocols for accuracy and clarity- Ensure study files are organized by date and category- Develop training processes and documentations for sterile product preparation per USP<797> and hazardous drug guidelines- Answer and direct phone calls and emails accordingly- Lead employees in sterile preparations- Oversee the environmental monitoring program per FDA/GMP guidelines- Develop a usage plan for sterile stocks to decrease waste and increase profits- Develop and maintain protocols and batch worksheets for sterile and non-sterile compounding- Perform non-sterile compounding per Investigational New Drug (IND) submissions - Adhere to the “Health Insurance Portability and Accountability Act” guidelines

- Operate equipment in the downstream production of Tanzeum in a cGMP environment- Responsible for buffer formulations and vessel cleanings (CIP and SIP)- Document all manufacturing activities clearly and accurately with cGMP compliance- Obtain the ability to troubleshoot- Attend daily team meetings to clarify team goals and designate individual tasks

Bachelor'S Degree In Pharmaceutical Sciences, Pharmaceutical Sciences

Highschool Diploma