Clinical Trial Specialist - Greater Boston Area
A Cambridge-based biopharmaceuticals company is seeking a Clinical Trial Specialist to join their Clinical Operations team. The Clinical Trial Specialist will oversee study management in addition to monitoring projects in accordance with SOPs, Good Clinical Practice, ICH Guidelines, and additional sponsor requirements. The Clinical Trial Specialist reports into Clinical Operations.
- Provide input into study management requirements
- Create tools related to monitoring and training for the study
- Have a clear understanding of monitoring practices and regulatory requirements
- Perform study cite visits to ensure proper execution of regulatory requirements
- Review study records (ex: case reports and consent forms)
- Implement corrective actions plans
- Produce quality study documentation in a timely fashion
- Collaborate with CRO teams and vendor teams
- Maintain sponsor and site communication
- Participate in departmental and company-wide meetings
- 2-5 years of monitoring and CRO experience
- CRO oversight of clinical trials
- Understands ICH GCP guidelines and the ability to evaluate medical data
- Organizational and time management skills
- Ability to travel up to 35%
- Clear alignment with the company's core values
If you or someone you know is interested in this position, please submit a resume to the attention of Isabella Martin i.martin(at sign)realstaffing.com and her team at Real Life Sciences in Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.
Good Clinical Practices (Gcp)
Corrective And Preventive Actions