Clinical Research Associate II/Senior Clinical Research Associate - All US Locations - FSP
ATLAS MEDICAL SERVICES LTD. STI. · United States · Today
RemoteRemoteAnalystFull-time
My research opens up new medical possibilities. And I do it Search Jobs Search Jobs Keyword Matching job links will appear below as you type. Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Clinical Research Associate II/Senior Clinical Research Associate - All US Locations - FSP Primary Location: United States, Florida, Remote Additional Locations: United States, Remote Job ID R0000045298 Category Clinical Trials Date Posted 08/27/2026 Apply Now Success profileAbout this rolePotential career pathEmployee insightsOur teamWhy Clinical Research Associates work at ParexelLearn about our culture Overview As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally. Success Profile Do you have these soft skills and interpersonal traits to succeed at Parexel? CommunicatorDetail-orientedFlexibleOrganizedProblem-solverSelf-starter Back to nav About This Role The Clinical Research Associate (CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. Monitoring Responsibilities And Study Conduct Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and qualityManage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are metDuring study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site deliveryInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sitesPartner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risksAttend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site levelConduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologiesMonitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolutionSubmit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metricsIdentify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issuesResolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelinesEnsures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activitiesSupport database release as neededMay undertake the responsibilities of an unblinded monitor where appropriate Clinical/Scientific And Site Monitoring Risk Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site teamInteract with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goalsSupport the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigatorsDrive Quality Event (QE) remediation, when applicableServe as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable Skills Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulationsMonitoring Experience: Minimum 2 years relevant experience in clinical research site monitoringMust be fluent in English and in the native language(s) of the country they will work inAbility to travel 60-80%Valid driver’s license and passport required Education Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Back to nav Share this job LinkedInFacebookXEmail Potential Career Path Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business. APEX CRA CRA I CRA II Senior CRA Project Management Subject Matter Expert People Management Back to nav Employee Insights Nick on a day in the life of a CRA Nick Burger | Senior Clinical Research Associate Watch Video Liliana on CRA tasks and our recognition program Liliana Belmares Flores | CRA Line Manager Watch Video Marlayna on why Parexel is a great place for CRAs Marlayna Fitts | CRA Line Manager Watch Video Back to nav TEAM IMPRESSIONS Back to nav Why Clinical Research Associates work at Parexel Patient-focused in everything we do We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused Supportive and inclusive environment We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals. Career growth and development We develop your skills through training, mentorship, and career advancement programs. Flexible work arrangements We focus on outputs and results, not where and when you work. Diverse therapeutic areas and project exposure We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams. Advanced Technology We recognize the importance of first-time quality to bring treatments to patients faster. Back to nav Learn About Our Culture Back to nav Back to nav Meet Adriane, a Senior Clinical Operations Leader sharing insights and tips Discover Adriane's role as a Clinical Operations Leader. She shares insights into her daily responsibilities, the skills crucial for success, and the rewarding challenges she faces. Learn how Parexel supported her career development and gain inspiration from her advice on professional growth. Learn More Meet Julie, a Senior Clinical Assistant, proud of her contribution Julie welcomes volunteers at the Early Phase Clinic reception in Berlin, manages payments, and caters to the volunteers in the kitchen. Learn More Meet Alexis, a Clinical Research Associate II championing patient care Alexis progressed from Administrative Assistant to CRA via Parexel's APEX program. She passionately works for the patients, sites and coworkers to make a difference. Off-duty, she enjoys time with her poodle, Millie, and baking shows. Learn More Clinical Operations Opportunities Are you passionate about making a difference in the fight against cancer and beyond? At Parexel's Global Clinical Operations, we are dedicated to putting patients at the heart of every clinical trial. With a global footprint and 5000 Clinical Operations team members worldwide, we are impacting clinical research. Learn More Meet Stacy Hurt, Chief Patient Officer at Parexel Insights on Parexel's patient-centric approach, innovative strategies, and authentic culture in clinical research. Learn how Stacy's unique experiences shape the future of clinical trials. Learn More Working as a Nurse in Clinical Research at Parexel Antje and Katharina share insights into working as a Nurse in Clinical Research, where innovative medications are developed through early-phase and first-in-human studies. Learn More Meet Laurias: Manager, Clinical Operations Laurias shares how Parexel has supported his career development from CRA to Clin Ops Manager and flexibility within the workplace. Learn More Video on Working With Heart® - Christina's Clinical Operations Manager Perspective View how Christina reflects on her work experience, her impact on patients and her management style of respect and growth. Christina is leading a team of Clinical Operations Leaders who manage groundbreaking trials in the biotech space. Learn More Meet Margaret: Clinical Research Nurse Find out why Margaret enjoys working as a Nurse in Clinical Research and working at Parexel, also how Parexel supports her in a way she hasn't experienced anywhere else. Learn More Meet Hina, an Executive Director championing excellence and empathy Parexel's Hina Saleem, Executive Director, Clinical Operations, shares how empathy and excellence drive her approach to clinical trial optimization and authentic leadership. Learn More Meet David, a champion for disability inclusion His leadership fosters workplace and clinical research inclusivity. Explore David's inspiring journey from combat medic to Parexel VP and Disability Inclusion Business Resource Group co-lead. Learn More Optimizing the clinical research workforce: An industry analysis by Parexel This comprehensive report benchmarks the trends and innovations having the greatest impact on drug development and identifies the skills required for today’s workforce. Learn More Meet iCRA Twins Marina Palumbo and Anna Korelis Double the passion and double the commitment to working With Heart™. Read on to learn more about these colleagues whose family and work lives are uniquely intertwined at Parexel! Learn More Meet Andrea: Senior Initiation Clinical Research Associate Andrea's story shows how teamwork, attention to detail and patient focus drive success at Parexel while finding fulfillment in helping innovative treatments reach patients faster. Learn More Emerging Talent Opportunities Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind. Learn More Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn More Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn More