Senior Clinical Trial Associate
About The Position
As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel.
Requirements
- Bachelor’s degree is required
- Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred
- Working knowledge of clinical protocols
- Minimum of 3 years of related industry experience is required
- Senior CTA requires 2 years' experience working as a Clinical Trial Associate.
- Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
- Experience with leading small group meetings and/or managing vendor relationships
- Highly motivated and enjoys working in a fast-paced, dynamic environment
- Excellent teamwork and collaboration skills
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
- Excellent written and verbal communication skills
- Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed
Responsibilities
- Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct
- Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors
- Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
- Conducts oversight of sample collection, shipment, and analyses
- Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead
- Identifies potential risks and proactively resolves issues with CROs
- Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s)
- Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information
- Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents
- Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms.
- Coordinates electronic distribution and/or shipment of study-related materials, as appropriate
- Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed
- Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)
- Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations
- Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
