Contractor, Clinical Trial Associate
Syndax Pharmaceuticals
6 months ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
The Role
- Work with the Clinical Operations team to support the conduct of clinical trials.
- Partner with Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Key Responsibilities
- Maintain the Trial Master Files (TMF) for assigned clinical trials (receipt, review, QC, tracking, and filing of required documents per SOPs).
- Ensure TMF is inspection ready.
- Provide TMF metrics to internal and external stakeholders.
- Work with cross-functional teams to adhere to the trial master oversight plan.
- Assist with development/maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits, and site payments.
- Assist Clinical Operations with CRO oversight as appropriate; attend/participate in Clinical Trial Working Groups as needed.
- Assist with reviewing monitoring visit reports.
- Review site-specific Informed Consent Forms.
- Track site feasibility questionnaires.
- Assist in planning meetings and events for the Clinical Operations team.
- Reconcile invoices to contracts/budget and assist with investigator site payments.
- Prepare and manage study communications (newsletters, study updates).
- Record, prepare, and distribute meeting minutes for assigned clinical trials (or as designated by VP of Clinical Operations).
- Support Clinical Trial Managers in preparing external/internal documentation in accordance with GCP and the study protocol.
Desired Experience/Education and Personal Attributes
- Two years’ experience in Veeva Vault.
- Two or more years’ clinical operations experience (CRO and Sponsor experience desired).
- Essential knowledge of FDA regulatory requirements and ICH/GCP guidelines.
- Demonstrated efficiency partnering with CROs and vendors.
- Proficiency: Veeva TMF, Word, Excel, PowerPoint, SmartSheet.
- Proactive, efficient work in a fast-paced, high-change environment.
- Excellent written and oral communication skills.
- Outstanding organization skills.
- Bachelor’s degree desired (science/healthcare related).
Location
- Open to candidates from any location; preference for East Coast locations.
- Work with the Clinical Operations team to support the conduct of clinical trials.
- Partner with Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Key Responsibilities
- Maintain the Trial Master Files (TMF) for assigned clinical trials (receipt, review, QC, tracking, and filing of required documents per SOPs).
- Ensure TMF is inspection ready.
- Provide TMF metrics to internal and external stakeholders.
- Work with cross-functional teams to adhere to the trial master oversight plan.
- Assist with development/maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits, and site payments.
- Assist Clinical Operations with CRO oversight as appropriate; attend/participate in Clinical Trial Working Groups as needed.
- Assist with reviewing monitoring visit reports.
- Review site-specific Informed Consent Forms.
- Track site feasibility questionnaires.
- Assist in planning meetings and events for the Clinical Operations team.
- Reconcile invoices to contracts/budget and assist with investigator site payments.
- Prepare and manage study communications (newsletters, study updates).
- Record, prepare, and distribute meeting minutes for assigned clinical trials (or as designated by VP of Clinical Operations).
- Support Clinical Trial Managers in preparing external/internal documentation in accordance with GCP and the study protocol.
Desired Experience/Education and Personal Attributes
- Two years’ experience in Veeva Vault.
- Two or more years’ clinical operations experience (CRO and Sponsor experience desired).
- Essential knowledge of FDA regulatory requirements and ICH/GCP guidelines.
- Demonstrated efficiency partnering with CROs and vendors.
- Proficiency: Veeva TMF, Word, Excel, PowerPoint, SmartSheet.
- Proactive, efficient work in a fast-paced, high-change environment.
- Excellent written and oral communication skills.
- Outstanding organization skills.
- Bachelor’s degree desired (science/healthcare related).
Location
- Open to candidates from any location; preference for East Coast locations.