Clinical Trial Associate - CONTRACT

CLINICAL TRIAL ASSOCIATE - CONTRACT

Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.

The Clinical Trial Associate (CTA) will provide support for the Clinical Operations team with the day-to-day activities of executing for one or more clinical trials during the trial start-up, conduct, and close-out periods, in accordance with the appropriate clinical trial standards including ICH/GCP and applicable regulations. This position is located at Sutro’s headquarters in South San Francisco, California.

Responsibilities:

•       Support the execution of clinical study from start to close-out
•       Support the Clinical Trial Manager on assigned tasks working closely on assigned study management activities
•       Maintain clinical study documents, ensuring compliance with Good Documentation Practices
•       Coordinate clinical operation team with meetings, prepare agenda, and meeting minutes
•       Manage the acquisition and distribution of clinical trial material
•       Maintain study files which includes filing documents in eTMF
•       Track study expenses and invoices as directed by CTM
•       Maintain study trackers and provide updates (data entry, enrollment etc)
• As a CTA you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring and site and vendor management on Phase 1 to Phase 3 trials
• You will work cross functionally within the Sutro team as well as with study sites, CROs and other vendors
• Responsible for site feasibility and recruitment, including review of Site Information Questionnaires
• Review assigned clinical documents (i.e. protocols, ICFs, and manuals) for clarity and accuracy and following ICH/GCP guidelines
• Reviews study plans, including; Clinical Monitoring, Communication, Project Management and electronic Trial Master File (eTMF) Management
• Review of data fields within the electronic data capture (EDC) systems, including performing and collating and downloading reports to support study management and data review
• Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements
• Reviews and tracks required essential regulatory documentation from clinical sites prior to study start-up as well as updates during study conduct
• Conducts site specific Informed Consent Form (ICF) review
• Reviews Site Visit Reports for accuracy, quality and consistency
• Assist with activities related to management of study vendors
• Assist in performance of TMF QC and reconciliation of findings
• Responsible for clinical team meeting scheduling, agendas and minutes
• Oversight of CRO and vendor minute review and finalization
• Maintains trackers and updates routine study dashboards
• Represents department in a professional manner; build and establish good relationships with investigators and all other study personnel
• Builds effective working relationships internally

Qualifications:

• University/college degree in health care or other scientifically related discipline is required. Bachelor’s degree is preferred
• 1-2 plus years of industry experience with 1 or more years of experience in= clinical operations