The Clinical Research Coordinator will be responsible for providing administrative and operational support to the clinical operations group. Specifically, this role will assist with the planning and coordinating of Synageva’s clinical research studies. The Coordinator will provide assistance with the collection, review, maintenance, and tracking of regulatory documents for clinical study sites and maintain the internal trial master files (TMF).
- Support the Clinical Operations study team to drive successful execution of global clinical studies in rare diseases.
- Set up, track, and maintain audit-ready clinical trial documentation. Manage and track regulatory/IRB/EC/REB documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents.
- Collect, review and track all necessary site-specific clinical regulatory documents throughout the course of each study. These documents include signed 1572s, financial disclosure forms, CVs, medical licenses, lab certificates, IRB approval letters and approved consent forms. Contact clinical sites and/or CROs as needed to complete study files and regulatory document collections.
- Review documents and submit them to appropriate departments such as Regulatory Affairs or Clinical Operations.
- Generate, finalize, and distribute study team agendas and meeting minutes.
- Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
- Create and assemble study manuals, binders, tools and presentations.
- Track CRA visits, monitoring reports and site follow-up letters.
- Coordinates contract processing.
- Process site payments.
- Track all protocol deviations.
- Ad hoc assignments and special projects on request.
- BA or BS degree, science or nursing degree preferred
- Strong organizational skills
- Must have high degree of accuracy and attention to detail
- Excellent writing, verbal communication, interpersonal and diplomacy skills
- Ability to handle and prioritize multiple assignments in a fast-paced environment
- Knowledge of GCP and FDA regulatory requirements
- Proficient in Word, Excel and Power Point
Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA, and research and production facilities in Athens, GA. Synageva is dedicated to developing novel orphan treatments for rare diseases. Our lead program, sebelipase alfa (formerly SBC-102), an enzyme replacement therapy for LAL Deficiency, is in global clinical trials and has been granted orphan designation by the FDA, the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. LAL Deficiency is a rare, serious and devastating disease that leads to significant morbidity and mortality. Synageva has additional orphan products in various stages of preclinical development. To ensure that these therapeutic candidates reach patients in need, Synageva has recruited a team with a proven track record of manufacturing, discovery, development, and commercial success within rare diseases.
Our mission is to deliver breakthrough medicines globally for patients suffering from rare, devastating diseases. Achieving this will result in a sustainable business that can continue to positively impact the lives of patients and their families, healthcare providers and our employees. Our success depends upon our ability to seek and retain principle-minded individuals who share our integrity, drive, energy and passion.
Indeed - 2 years ago
Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA,...