Sutro Biopharma, Inc.
Clinical Trial Associate - CONTRACT
Sutro Biopharma, Inc., South San Francisco, California, us, 94083
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. The Clinical Trial Associate (CTA) will support the day‑to‑day execution of multiple clinical trials across the start‑up, conduct, and close‑out phases, in accordance with 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, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines)
Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role
Proven ability to proactively identify and resolve/refer project‑related operational issues; ability to work independently on routine assignments, or under supervision on new assignments.
Ability to handle a moderate volume of highly complex tasks within a given timeline.
Requires strong organizational skills, attention to detail and ability to prioritize and problem solve.
Willingness to travel as necessary, consistent with project needs
Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
Some travel (domestic and international), up to 15%
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $85,000 - $115,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third‑party agencies.
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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, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines)
Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role
Proven ability to proactively identify and resolve/refer project‑related operational issues; ability to work independently on routine assignments, or under supervision on new assignments.
Ability to handle a moderate volume of highly complex tasks within a given timeline.
Requires strong organizational skills, attention to detail and ability to prioritize and problem solve.
Willingness to travel as necessary, consistent with project needs
Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
Some travel (domestic and international), up to 15%
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $85,000 - $115,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third‑party agencies.
#J-18808-Ljbffr