Lead Clinical Research Associate
Newton , MA
- The Lead Clinical Research Associate will oversee the progress of clinical research associates (CRAs) and clinical sites by conducting pre-study, initiation, interim, and close out visits to sites. In addition this professional will monitor clinical trials in accordance with Good Clinical Practices, work closely with CRAs and Clinical Project Manager to ensure high quality data is provided, and ensure compliance is maintained across all monitoring activities.The Lead Clinical Research Associate should have a track record of overseeing clinical trials, assisting in the development and implementation of Standard Operating Procedures (SOP), and utilizing metric tools to ensure timelines are being met.
- Bachelor's degree or nursing qualification.
- Experience working in clinical research within a pharmaceutical company, CRO, or similar organization.
- Proven Oncology experience.
- Strong knowledge of clinical research process and medical terminology.
- Proven understanding of GCP/ICH guidelines.
- Knowledge of regulatory requirements and guidelines governing clinical research.
- Proven understanding of basic data processing functions, including electronic data capture.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
- Able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization.
- Strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Excellent written and verbal communication skills.
- Ability to express complex ideas to study personnel at research and clinical institutions.
PLEASE NOTE: 3RD PARTIES/SUBCONTRACTORS/SUBCONTRACT AGENCIES ARE NOT ELIGIBLE FOR THIS POSITION. SUBCONTRACT AGENCIES NEED NOT APPLY.