Clinical Research Associate I
Department/Group: Clinical Operations
Location: Burlingame, CA
Position Type: Full time
Role and Responsibilities
- Assists in the design, planning and implementation of the overall strategies and plans of clinical research projects
- Monitors the entry of clinical data by clinical sites
- Communicates with sites, CROs and other vendors and maintains effective management of protocol objectives and study issues
- May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms.
- Reviews site’s informed consent forms against the consent template for presence of GCP requirements, protocol specific information and for accuracy
- Proficient in coordination and review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
- Assists with sites and vendors issues and corrective action prevention plan resolutions
- Ensures ongoing tracking of IND Safety Reports for assigned sites and works with Clinical Monitors to support drug safety with resolution of open queries
- Assists with the management of clinical site contracts, budgets and invoice process
- Assists with vendor selection and management
- Review, reconcile and process site and vendor invoices as assigned
- Partners with team members and cross-functional teams
- Thorough knowledge of FDA clinical trial regulations and ICH E6 clinical trial guidelines..
- Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
- Develops increased professional expertise through familiarity with clinical literature and participates in project team meetings.
- May conduct clinical monitoring of clinical sites to supervise and coordinate clinical studies.
- May assist with the creation and maintenance protocols, ICFS and other study management documents.
- May require travel to clinical sites.
- Works on problems of a moderate scope where analysis of situations or data requires review of a variety of factors
- Exercises judgment within defined procedures and practices to determine appropriate action
- Receives general instructions on routine work, detailed instructions on new projects or assignments
- Applies company policies and procedures to resolve a variety of issues
Qualifications and Education Requirements
- Bachelor’s degree required
- 2+ years of related experience required
- 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, agility, and drive.
Join our Team
Local candidates only please! If you are interested, please submit a cover letter and your resume to firstname.lastname@example.org