Job Description

The Clinical Research Associate is responsible for supporting and overseeing clinical studies from study concept through study completion for global pre- and post-market trials. This position will perform the required job duties with guidance from the Sr. Director of Clinical Affairs to ensure trial timelines, costs, and quality metrics are met while maintaining data integrity, patient safety, and regulatory adherence to appropriate standards. ** This is a REMOTE role, with preference to candidates in the New Haven, CT or Tampa, FL or surrounding areas. ** Job Responsibilities Support clinical study operations, including site qualification, site initiation, site management, supply/device shipment, study monitoring, and close out. Assist in regulatory submissions for Ethics Committee (EC)/Institutional Review Board (IRB) review. Manage the preparation, handling, filing, and archiving of clinical documentation and study reports according to SOPs, Trial Master File (TMF) guidelines, and study requirements. Support Clinical Data Management (CDM) activities including design and content of case report forms, completion guidelines, and support/testing (UAT) of an EDC system. Assist in the development of study monitoring plans and monitor studies as directed to ensure compliance with study protocols and regulatory requirements. Train study staff on protocol requirements, clinical study procedures and surgical techniques. Assist with, and attend, Investigator Meetings for assigned studies. Collaborate with cross-functional teams (R&D, Regulatory Affairs, Quality Assurance, Sales, Marketing) to align research objectives with product evidence generation requirements. Maintain study progress reports and provide status updates to stakeholders. Qualifications: Bachelor's degree in biology, chemistry, engineering or related field. 2+ years of clinical research experience, preferably within the medical device industry. Preferred Qualifications Experience in a clinical setting (e.g. health care facility, clinic practice, operating room) working with nursing staff and physicians. Experience in the field of orthopedic surgery, sports medicine, or minimally invasive / robotic laparoscopic surgery. Experience in pre-market and post-market clinical studies for medical devices. Certified Clinical Research Professional (CCRP) or Clinical Research Associate (CCRA) Certification Strong knowledge of FDA regulations, ISO 14155, and clinical trial management for medical devices. Experience with electronic data capture (EDC) systems and clinical trial management software. Exceptional attention to detail, organizational skills, and the ability to manage multiple projects. Excellent written and oral communication skills and interpersonal skills with high attention to detail. Ability to submit credentials to access healthcare facilities and operating rooms (proof of vaccinations, compliance with training certifications and other documentation as required). Travel: 20-40% This role is not eligible for sponsorship. Disclosure as required by applicable law, the annual salary range for this position is $70,000 to $109,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED's good faith belief at the time of this posting. This job posting is anticipated to close on August 31, 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them. Benefits: CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage Short & long term disability plus life insurance -- cost paid fully by CONMED Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period Employee Stock Purchase Plan -- allows stock purchases at discounted price Tuition assistance for undergraduate and graduate level courses Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives! CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment. Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5. #J-18808-Ljbffr Davita Inc.

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