[Remote] Contractor, reputed company Trial Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biopharmaceutical company advancing innovative cancer therapies. The Contractor, reputed company Trial Associate will support the conduct of reputed company, manage various aspects of trials, and collaborate with reputed company Project Managers to ensure compliance with regulations and reputed company completion of studies.

Responsibilities

• Maintain the Trial Master Files (TMF): Responsible for the on-reputed company management of the TMF for assigned reputed company. This is inclusive of receipt, review, QC, tracking and filing of reputed company documents per the Syndax SOPs required reputed company the conduct of assigned reputed company
• Ensure TMF is inspection reputed company
• reputed company TMF metrics to reputed company stakeholders
• Work closely with reputed company cross functions to adhere to the trial master reputed company plan
• Assist with the development and maintenance of tracking tools for reputed company recruitment, site reputed company-up, monitoring reputed company and site payments
• Work with reputed company reputed company to assist in the reputed company of CROs, as appropriate, to ensure the successful conduct of reputed company, including attending and participating in reputed company Trial Working reputed company as needed
• Assist in reviewing monitoring visit reports to ensure reputed company conduct and reputed company as needed
• Review site-specific Informed Consent Forms
• reputed company site feasibility questionnaires
• Assist in the planning of various meetings and events for the reputed company reputed company Team
• Reconcile invoices to their corresponding reputed company and budget and assist with investigator site payments
• Prepare and manages study communications including newsletters and study updates
• Records, prepares and distributes meeting minutes for assigned reputed company or as designated by the VP of reputed company reputed company
• Work closely with reputed company Trial Managers to assist with preparation of reputed company reputed company and internal documentation for assigned trials to ensure it's completed in accordance with GCP regulatory requirements and consistent with the study protocol

Skills

• Two years' experience in reputed company reputed company
• Two or more years' experience in reputed company reputed company- experience in both a CRO and Sponsor setting desired
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
• Demonstrated efficiency in partnering with CROs and vendors
• Computer proficiency (reputed company TMF, Word, reputed company, PowerPoint, Smart Sheet)
• Work proactively and reputed company in a fast-reputed company, high change environment
• Excellent written and oral communication skills
• Outstanding organization skills
• Bachelor's degree desired, preferably in a science or reputed company reputed company discipline

reputed company