Senior Clinical Trial Associate
Kymera Therapeutics
4 hours ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Senior Clinical Trial Associate (Sr. CTA) — Role Responsibilities
- Supports the Clinical Operations Team to deliver clinical trials in accordance with applicable regulations, timelines, and budget.
- Coordinates clinical trial logistics, tracking, and administrative tasks from protocol concept through clinical study report.
- Collaborates with internal teams to support execution of Kymera-sponsored clinical trials.
- Assists with clinical operations oversight, including review of Monitoring Visit Reports, Study Plans, and Essential Document Packets.
- Maintains the eTMF in inspection readiness via QC, reconciliation, and audit/inspection support to ensure GCP and regulatory compliance.
- Ensures study issues and decision-related correspondence are maintained throughout the trial.
- Maintains the Action Decision Issue Log and tracks actions to completion.
- May contribute to development/review of study documents (e.g., informed consent forms, study templates).
- Performs reconciliations and tracking activities.
- Manages trial vendors with oversight.
- Routes, tracks, and coordinates Site and CRO/Vendor Confidential Disclosure Agreements (CDAs) and other contracts with Clinical Operations, Legal, and Finance.
- Leads eTMF archiving and coordinates file transfer and reconciliation with CROs at study closeout.
- Maintains internal SharePoint site (folder creation, filing).
- Drafts internal agendas, keeps meeting minutes, and manages external partners for agendas/minutes execution.
- Assists with logistics coordination for investigator and external vendor meetings.
- Participates in functional initiatives (SOP development/review, staff training, system/process improvement).
- Develops and maintains collaborative relationships with cross-functional teams and external vendors.
- Participates in co-monitoring visits as needed.
Skills and Experience / Qualifications
- BS/BA degree; preference for scientific or health-related field.
- 3+ years of clinical trial execution experience, including at least 1 year on the sponsor side.
- Knowledge of ICH and Good Clinical Practice (GCP) Guidelines.
- Excellent verbal and written communication, organizational, and problem-solving skills.
- Experience building and managing external contract research relationships.
Compensation
- Anticipated base salary range: $90,000–$155,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Supports the Clinical Operations Team to deliver clinical trials in accordance with applicable regulations, timelines, and budget.
- Coordinates clinical trial logistics, tracking, and administrative tasks from protocol concept through clinical study report.
- Collaborates with internal teams to support execution of Kymera-sponsored clinical trials.
- Assists with clinical operations oversight, including review of Monitoring Visit Reports, Study Plans, and Essential Document Packets.
- Maintains the eTMF in inspection readiness via QC, reconciliation, and audit/inspection support to ensure GCP and regulatory compliance.
- Ensures study issues and decision-related correspondence are maintained throughout the trial.
- Maintains the Action Decision Issue Log and tracks actions to completion.
- May contribute to development/review of study documents (e.g., informed consent forms, study templates).
- Performs reconciliations and tracking activities.
- Manages trial vendors with oversight.
- Routes, tracks, and coordinates Site and CRO/Vendor Confidential Disclosure Agreements (CDAs) and other contracts with Clinical Operations, Legal, and Finance.
- Leads eTMF archiving and coordinates file transfer and reconciliation with CROs at study closeout.
- Maintains internal SharePoint site (folder creation, filing).
- Drafts internal agendas, keeps meeting minutes, and manages external partners for agendas/minutes execution.
- Assists with logistics coordination for investigator and external vendor meetings.
- Participates in functional initiatives (SOP development/review, staff training, system/process improvement).
- Develops and maintains collaborative relationships with cross-functional teams and external vendors.
- Participates in co-monitoring visits as needed.
Skills and Experience / Qualifications
- BS/BA degree; preference for scientific or health-related field.
- 3+ years of clinical trial execution experience, including at least 1 year on the sponsor side.
- Knowledge of ICH and Good Clinical Practice (GCP) Guidelines.
- Excellent verbal and written communication, organizational, and problem-solving skills.
- Experience building and managing external contract research relationships.
Compensation
- Anticipated base salary range: $90,000–$155,000; eligibility for annual bonus, equity participation, and comprehensive benefits.