Clinical Research Associate

Job Title:

Clinical Research Associate Job Description We are seeking a highly skilled and experienced Clinical Research Associate (CRA) to join our team, focusing on Phase I-III clinical trials within the Autoimmune therapeutic area. The ideal candidate will have expertise in Cell & Gene Therapy and will be responsible for monitoring and managing clinical trial activities, ensuring compliance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This role requires meticulous attention to detail, excellent communication skills, and the ability to work effectively within a multidisciplinary team environment. Responsibilities Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol. Communicate with medical site staff, including coordinators, clinical research physicians, and their site staff. Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff. Verify medical records and research source documentation against case report form data, ensuring good documentation practices are adhered to and communicating protocol deviations appropriately. Perform on-site and virtual/remote monitoring activities with a risk-based monitoring approach to identify site deviations/deficiencies and implement corrective/preventive actions. Ensure the investigator enrolls only eligible subjects. Review regulatory documents and maintain investigational product/drug accountability and inventory. Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting. Assess the clinical research site's patient recruitment and retention success and offer suggestions for improvement. Complete monitoring reports and follow-up letters, providing summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance. Essential Skills Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred. Minimum of 4 years of experience as a Clinical Research Associate. Demonstrated experience in Phase I-III clinical trials within the Autoimmune therapeutic area. Demonstrated expertise in Cell & Gene Therapy trials. Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements. Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment. Excellent interpersonal, communication, and organizational skills. Ability to travel domestically and internationally, as required, up to 50%. Additional Skills & Qualifications Certification as a Clinical Research Professional (CCRP) or equivalent is a plus. Proficiency in Microsoft Office Suite and familiarity with electronic data capture systems. Work Environment The role involves up to 50% travel, primarily within the US. Both onsite and remote monitoring will be required. There is an expectation for the candidate to visit the company headquarters once per quarter. Preference is given to candidates based in Maryland, though this is not a requirement. The team currently includes three other CRAs. Job Type & Location This is a Permanent position based out of Gaithersburg, MD. Pay and Benefits The pay range for this position is $110000.00 - $120000.00/yr. Company Benefits Company Benefits Workplace Type This is a hybrid position in Gaithersburg,MD. Application Deadline This position is anticipated to close on Mar 25, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent 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. 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.