Clinical Research Associate (CRA)

Job DescriptionDuties / ResponsibilitiesThe Clinical Research Associate (CRA) will support IVD and specimen collection studies in compliance with Federal Regulations, ICH GCP, FDA, and IRB guidelines.Responsibilities include: assisting senior staff with study planning and execution; investigator site evaluation, selection, training, and management; and coordination of study meetings. The CRA will be responsible for writing and assembling regulatory submissions, drafting basic study protocols and reports, monitoring investigational sites to ensure protocol adherence, ensuring timely patient enrollment, and overseeing CRF retrieval and processing (including data clean up and classification). The role includes contributing to study summaries and serving as a lead or mentor to junior CRAs when applicable.Experience: 5+ years of clinical research monitoring experience, preferably at a Senior CRA level or ready for promotion to Senior CRA.Key Skills• Independent site monitoring and site management• Strong working knowledge of ICH GCP, FDA, and IRB requirements, including audit readiness• Proven experience reviewing medical records and source documentation• Strong cross functional communication skills (primary site contact; collaboration with study teams and management)• Leadership experience, including mentoring junior CRAs and acting as Lead CRA across multiple protocols and sitesPreferred Experience• Demonstrated career stability with professional growth (not frequent short term roles)• Experience in the IVD therapeutic area• Neurology study experience• Background working for or with a sponsor organizationEducation: Bachelor's degree in Life Sciences (required)Pay ranges between 38-42/hr based on experience Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.

Created: 2026-04-18