Senior Clinical Trial Associate (CTA)

Reports to: Vice President, Head of Clinical Operations

Location:  This position may be performed remotely with travel to the Boston area as needed.

Position Summary

This role provides project support in the initiation, execution and close out of domestic and international clinical studies. The Senior CTA has the responsibility to support the project teams to achieve quality results in a cost-effective and timely manner with increasing responsibility and scope. They assist the clinical team with establishing key practices and procedures.

Primary Responsibilities

• Support the Clinical team in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations
• Coordinate, provide set up, and attend project meetings including: internal team and CRO/ vendor meetings
• Set-up, update and maintain clinical trial-related trackers such as critical regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
• Provide detail reviews for clinical trial documents, e.g. protocol, informed consent form, case report form
• Recognize and flag potential errors and deviations from timelines to CTM and team members
• Assist with IRB/EC and regulatory submissions
• Perform TMF reviews to ensure completeness and inspection readiness
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides)
• Assist with identifying and implementing best practices and continuous improvement projects

Qualifications and Key Success Factors

• Bachelor’s degree in life sciences or healthcare field preferred. In lieu of degree, 4 or more years of relevant experience may suffice
• 2 years of relevant hands-on drug development experience in Sponsor setting
• Knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
• Excellent communication and organizational skills with experience working in a team across multiple functional areas, (e.g. Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)
• Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve
• Self-motivated and able to work autonomously, as well as a member of a collaborative team
• Highly-organized and detail-oriented with a passion to deliver quality results
• Strong verbal and written communication skills with an ability to build relationships internally and externally

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes: 

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide base salary compensation in the range of $123,000 to $137,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.

Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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