Senior Clinical Trial Associate

Location:   This position may be performed remotely but requires flexibility and a willingness to travel as needed.  Position Summary At Praxis, our Senior Clinical Trial Associates are more than project coordinators—they’re builders, critical thinkers, and collaborators who help translate cutting-edge science into real impact for patients with CNS disorders. In this role, you’ll support the clinical team in driving trials forward—on time, with rigor, and always with the patient in mind. You’ll bring operational excellence, strong communication, and a bias toward action to every phase of the study lifecycle. This is a high-trust, high-impact role for someone who thrives in a fast-moving environment and is energized by doing things differently—and better.   Primary Responsibilities <ul><li>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 </li><li>Coordinate, provide set up, and attend project meetings including: internal team and CRO/vendor meetings </li><li>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. </li><li>Provide detail reviews for clinical trial documents, e.g. protocol, informed consent form, case report form </li><li>Recognize and flag potential errors and deviations from timelines to CTM and team members </li><li>Assist with IRB/EC and regulatory submissions </li><li>Perform TMF reviews to ensure completeness and inspection readiness </li><li>Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) </li><li>Assist with identifying and implementing best practices and continuous improvement projects </li><li>Act as a backup to the assigned Clinical Trial Manager (CTM) to maintain operational continuity during absences or peak workload periods. </li><li>Support oversight of CROs, vendors, and study sites to ensure adherence to timelines, deliverables, and quality standards. </li><li>Review study documents (e.g., monitoring plans, ICFs, training materials, and site communications) as delegated by the CTM. </li><li>Maintain awareness of study milestones and proactively coordinate with functional leads to avoid operational gaps. </li></ul> Qualifications and Key Success Factors <ul><li>Bachelor’s degree in life sciences or healthcare field preferred. In lieu of degree, 4 or more years of relevant experience may suffice </li><li>2+ years of relevant hands-on drug development experience in Sponsor setting </li><li>Knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements </li><li>Experience with VEEVA Vault strongly preferred.</li><li>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) </li><li>Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit </li><li>Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve </li><li>Self-motivated and able to work autonomously, as well as a member of a collaborative team </li><li>Highly-organized and detail-oriented with a passion to deliver quality results </li><li>Strong verbal and written communication skills with an ability to build relationships internally and externally </li><li>The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. </li></ul>    Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!  <div class="content-pay-transparency"><div class="pay-input"><div class="title">Annualized Base Salary</div><div class="pay-range">$115,000—$126,000 USD</div></div></div><div class="content-conclusion">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. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to <a href="mailto:careers@praxismedicines.com">careers@praxismedicines.com</a>. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.</div>

Senior Clinical Trial Associate

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