Senior Clinical Research Associate
Department/Group: Clinical Operations
Location: Burlingame, CA
Position Type: Full time
Role and Responsibilities
- Plans, implements and monitors clinical research projects ensuring that studies are conducted per established procedures, policies, regulations and GCP.
- Actively participates as a member of cross functional teams overseeing current projects and planning of future projects
- Evaluates and analyzes clinical data, ensuring study and data integrity as well as ensuring subjects rights, welfare and safety are protected
- Must have in-depth knowledge of good clinical practices (GCP), regulatory requirements and standard operating procedures
- Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives
- Maintains a high level of professional expertise through familiarity with clinical literature and participation in project team meetings, professional meetings and other educational opportunities
- May draft materials or contribute to the development of clinical protocols, informed consent documents, project management plans, , patient instruction guides and case report forms
- May require travel to conduct clinical monitoring of clinical sites to ensure data quality and adherence to the protocol
- Works on complex issues where timely analysis of situations or data requires an in-depth evaluation of variable factors and is critical to meeting the scheduled goals of the project.
- Determines methods and procedures on new assignments
- May coordinate activities of other personnel (team lead)
- Works under the direction of the Clinical Project Manager or Senior Clinical Trial Manager
Qualifications and Education Requirements
- Bachelor’s degree in the biological sciences, masters preferred
- Minimum 2 years’ experience as a CRA supporting an oncology clinical trial
- 5+ years of related experience required
- Demonstrated leadership capabilities especially in regard to CRO management
- GCP compliance management and QC oversite of clinical trials capabilities
- Excellent teamwork and collaboration skills
- Proficient with Microsoft Office.
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.
Join our Team
LOCAL Bay Area Candidates only
If you are interested, please submit a cover letter and your resume to email@example.com