Clinical Research Associate

Syndax Pharmaceuticals is looking for a Clinical Research Associate

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

Perform a key role in building relationships with site Clinical Coordinators, Study Investigators, and Service Provider partners and contribute significantly to the execution of the clinical trial. Collaborate with cross-functional team members in this high-profile role. Communicate regularly with CTMs regarding work progress. Apply knowledge of clinical site oversight and other monitoring activities as a co-monitor with contract CRAs and as a primary site monitor for study sites.

Key Responsibilities:

• Assist in the development of information/consent forms.
• Assist in the development of study training materials, study plans and study tools.
• Review Monitoring Plans and monitoring visit reports.
• Track metrics for monitoring visits and monitoring visit reports and document trends.
• Conduct remote and on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study.
• Work closely with Clinical Supplies to resolve outstanding site action items.
• If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff.
• Ensure the Monitoring Plan is followed.
• Perform in-house clinical study data review.
• Collect and review study site regulatory documents for study start-up, annual reviews, and study close-out.
• Create and maintain study-related tracking tools.
• Participate as needed in site study drug training (unblinded CRA role).
• Assist in the maintenance of the clinical trial master file; perform study file audits.
• Participate in QC of study documents (protocol, ICF template(s), TMF, etc.) and the UAT of EDC and IRT systems.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO’s CRAs on these activities.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions.
• Daily interaction with Clinical Operations management and members of the cross-functional study team.
• Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.).
• Lead and partake in regular team meeting/teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary.
• Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified.
  
  

Desired Experience/Education and Personal Attributes:

• BS degree in life sciences or healthcare discipline, Master’s degree is preferred; at least 3 years of clinical operations experience including at least 2 years of experience monitoring oncology trials preferred.
• Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
• Good verbal and written communication skills; enjoys frequent interaction with others.
• Able to prioritize tasks and work independently.
• Works collaboratively in a small team environment.
• Experience working with Risk-Based Monitoring and Centralized Monitoring
• Experience working with EMR, EDC, eTMF and CTMS systems.
• Able to travel an average of 25%, both domestically and internationally.
  
  

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $110,000 -$125,000.

About Syndax:

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.