<p>Job Title: Clinical Trial Associate</p> <p>Job Description</p> <p>The Clinical Trial Associate supports the planning, execution, and close-out of investigational clinical studies in alignment with Good Clinical Practice (GCP), applicable regulations, and internal standard operating procedures. Working closely with Clinical Trial Managers and Clinical Operations leadership, this role coordinates key clinical trial documents, maintains tracking systems and electronic trial master files, and helps ensure operational excellence across all phases of a study. This position is ideal for a detail-oriented professional who thrives in a fast-paced, rapidly growing environment and wants to contribute to groundbreaking clinical trials with the potential to significantly improve patients' lives.</p> <p>Responsibilities</p> <ul> <li>Organize and maintain tracking systems and tools to support the conduct of clinical studies from start-up through maintenance and close-out. </li><li>Collect clinical trial information and distribute it to internal project teams, contract research organizations (CROs), and other stakeholders in a timely and accurate manner. </li><li>Schedule and coordinate study meetings, including preparing materials and agendas, recording decisions and action items, and disseminating meeting minutes. </li><li>Prepare, manage, and maintain internal meeting agendas and minutes, ensuring clear documentation of key discussions and outcomes. </li><li>Update, maintain, and perform quality control checks on the electronic Trial Master File (eTMF), SharePoint sites, and shared drives to ensure completeness and inspection readiness. </li><li>Coordinate training activities for assigned clinical studies, including tracking completion and maintaining relevant documentation. </li><li>Track study laboratory samples and provide support for vendor management related to sample handling and logistics. </li><li>Set up, manage, and track new vendors and purchase orders in the financial system to support clinical study activities. </li><li>Coordinate, manage, and track version control of clinical documents, ensuring that current versions are clearly identified and accessible. </li><li>Prioritize and manage multiple tasks and projects with limited supervision while meeting established timelines. </li><li>Assist in the coordination and tracking of clinical supply shipments, including review and approval of regulatory documentation packages associated with those shipments. </li><li>Support the Clinical Operations team with specific projects and operational initiatives as assigned. </li><li>Effectively communicate with study team members and external partners to address operational challenges and facilitate timely issue resolution. </li><li>Participate in inter-departmental workgroups to create, refine, or enhance clinical operations processes and best practices. </li></ul> <p>Essential Skills</p> <ul> <li>BS/BA degree or equivalent education. </li><li>At least 1 year of experience in clinical operations within a sponsor company. </li><li>Knowledge of the drug development process and clinical operations workflows, including study start-up, maintenance, and close-out procedures. </li><li>Understanding and practical application of Good Clinical Practice (GCP) and relevant Code of Federal Regulations in the conduct of clinical studies. </li><li>Hands-on experience with electronic Trial Master File (eTMF) systems, including the ability to apply essential document requirements when filing documents. </li><li>Proficiency with Microsoft Excel, Word, and PowerPoint for documentation, tracking, and reporting. </li><li>Effective written and oral communication skills, with the ability to clearly convey information to cross-functional team members and external partners. </li><li>Strong organizational skills with the ability to prioritize and manage multiple tasks and timelines simultaneously. </li><li>Demonstrated ability to identify issues, propose solutions, and follow through to resolution. </li><li>Strong attention to detail and commitment to high-quality documentation and data integrity. </li><li>Ability and willingness to work in a flexible, fast-paced environment and adapt to changing priorities. </li><li>Effective interpersonal and teamwork skills, with the ability to collaborate across functions and levels. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Additional years of clinical operations experience within a sponsor environment. </li><li>Experience working on global clinical studies, particularly in an outsourced CRO model. </li><li>Experience in clinical drug development involving First-in-Human trials. </li><li>Exposure to or experience with regulatory affairs activities, including IND and CTA submissions. </li><li>Knowledge of therapeutic areas such as transplant, oncology, or cellular therapies. </li><li>Familiarity with Microsoft Project and SharePoint for project planning and document management. </li><li>Ability to persevere and maintain energy, drive, and initiative when facing challenges. </li><li>Results-oriented mindset with a focus on driving issues to closure and achieving study milestones. </li><li>Strong planning skills with a disciplined and thorough approach to organizing work and processes. </li><li>Adaptability and flexibility to work effectively in a variety of situations and to embrace organizational and role-related changes. </li><li>Collaborative communication style that supports effective teamwork and shared problem-solving. </li></ul> <p>Work Environment</p> <p>This role operates in a dynamic, fast-paced clinical development environment that emphasizes collaboration, quality, and patient-focused innovation. The position requires on-site presence at least three days per week, with flexibility in which days are spent in the office. Team members work closely with Clinical Operations, cross-functional partners, and external CROs and vendors, using tools such as eTMF systems, SharePoint, and the Microsoft Office suite to manage documentation and trial activities. The environment supports learning, growth, and professional development, with opportunities to contribute to high-impact, cutting-edge clinical trials while working alongside a dedicated and mission-driven team.</p> <p>Job Type & Location</p> <p>This is a Contract position based out of South Boston, MA.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $45.00 - $45.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a hybrid position in South Boston,MA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on May 15, 2026.</p> <p>Diversity, Equity & Inclusion</p> <p>At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:</p> <ul> <li>Hiring diverse talent </li><li>Maintaining an inclusive environment through persistent self-reflection </li><li>Building a culture of care, engagement, and recognition with clear outcomes </li><li>Ensuring growth opportunities for our people </li></ul> <p>Actalent is an equal opportunity employer.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.</p> <p>Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.</p>