We anticipate the application window for this opening will close on - 23 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Medtronic Clinical Studies team is seeking a detail‑oriented and motivated professional to support the execution of clinical studies through effective data and document coordination. In this role, you will contribute to the development, maintenance, and quality oversight of clinical study data and files, partnering closely with cross‑functional teams to ensure accuracy, completeness, and compliance with study protocols and regulatory requirements. Your work will directly support high‑quality clinical evidence generation and help advance Medtronic’s mission of alleviating pain, restoring health, and extending life for patients around the world. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. Responsibilities may include the following and other duties may be assigned. - Supports clinical studies by executing and maintaining one or more of the following areas. - Data coordination – actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements. - Ensures timely and quality completion of data forms, verifies study data, and generates, manages, and resolves data discrepancies. - May process compensation and identify and resolve compensation discrepancies. - Document coordination – creates and manages the clinical study files and oversees the organization and distribution of clinical study documents. - Assists with periodic audits of clinical study files for completeness and accuracy. Minimum requirements: - High school diploma or equivalent with 6+ years of relevant administrative, clinical research, or data coordination experience - Medtronic experience Nice to Have: - Has high degree of initiative - Work may be done without established procedures - Advanced practical knowledge of the CSC role - Ability to train, mentor or coach others in processes alongside manager - Ability to introduce or implement considerations for process improvements - Experience supporting clinical studies, research operations, or regulated projects - Strong attention to detail with the ability to manage and verify data for accuracy and completeness - Experience coordinating documentation, maintaining files, and supporting audits or reviews - Ability to manage multiple tasks and deadlines in a fast‑paced environment - Proficiency with standard computer applications (e.g., Microsoft Office, databases, document management systems) - Strong written and verbal communication skills - Experience working within clinical research, clinical safety, or medical device environments - Familiarity with clinical data management activities, including case report forms, databases, and data discrepancy resolution - Experience working with SOPs, regulated processes, or quality systems - Prior experience supporting audits or inspections - Experience processing or reconciling study‑related compensation or payments - Familiarity with Medtronic Standard Study Management Process (SSMP) or similar frameworks For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$62,400.00 - $93,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Premier Research is looking for a Clinical Trial Associate II (TMF Specialist) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. - We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. - Your ideas influence the way we work, and your voice matters here. - As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you'll be doing: - Assists in eTMF (electronic Trial Master File) filing and administration by submitting documents and/or files, conducting document review, supporting document query resolution, ensuring completeness, and conducting final site level review along with final document collection - Creates and maintains tracking tools and database repositories for operational data including Key Performance Indicators (KPIs) and quality metrics - Participates in project team meetings, prepares meeting minutes, and maintains action/decision logs - Reports document collection and tracking issues to functional lead and/or study team, and assist more junior CTA team, as required - Maintains clinical inspection readiness and supports regulatory inspections and/or audits as required What we are searching for: - Bachelor's degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience - 2 to 5 years of practical experience with clinical trial administration (e.g. – Inhouse CRA, CTA, site administration, clinical monitoring) preferred - Strong knowledge of clinical studies and ability to support study team with functionality and use of TMF in accordance with study-specific TMF Plan, SOPs, and study-specific processes - Strong communication and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities - Preferred Location: East Coast - Please note this is a 9 month 1099 contractor opportunity from April-December 2026 Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Role Description The Contractor CRA will perform various responsibilities including: - Site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely). - Ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. - Evaluating site performance and providing recommendations for site-specific actions. - Maintaining knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs. - Verifying informed consent processes for each subject/patient. - Protecting subject/patient confidentiality and assessing safety factors affecting clinical data integrity. - Conducting Source Document Reviews and verifying clinical data accuracy. - Applying query resolution techniques and providing guidance to site staff. - Verifying compliance with electronic data capture requirements. - Performing investigational product inventory and ensuring proper dispensing and administration. - Reviewing the Investigator Site File for accuracy and completeness. - Documenting activities via confirmation letters, trip reports, and other required documents. - Supporting subject/patient recruitment and retention strategies. - Managing site-level activities to meet project objectives and timelines. - Acting as a primary liaison with study site personnel. - Preparing for and attending Investigator Meetings and sponsor meetings. - Providing guidance towards audit readiness standards. - May supervise, train, and mentor junior CRAs. - For Real World Late Phase (RWLP), additional responsibilities include: - Site support throughout the study lifecycle. - Chart abstraction activities and data collection. - Collaborating with Sponsor and local staff. - Training junior staff as needed. - Identifying operational efficiencies and process improvements. - Participating in bid defense meetings and providing input into RFPs. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Good computer skills and ability to embrace new technologies. - Excellent communication, presentation, and interpersonal skills. - Moderate level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis. Benefits - Company car or car allowance. - Health benefits including Medical, Dental, and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on performance. - Flexible paid time off (PTO) and sick time. Company Description Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Over the past 5 years, we have worked with: - 94% of all Novel FDA Approved Drugs. - 95% of EMA Authorized Products. - Over 200 Studies across 73,000 Sites and 675,000+ Trial patients. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance.

Role Description Experienced Clinical Research Associate - Full-Service - Ophthalmology - Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. - Conducts Source Document Review of appropriate site source documents and medical records. - Verifies required clinical data entered in the case report form (CRF) is accurate and complete. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. - Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt to changing priorities to achieve goals/targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. - Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. - For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. - Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out. - Knowledge of local requirements for real world late phase study designs. - Chart abstraction activities and data collection. - Collaboration with Sponsor affiliates, medical science liaisons and local country staff. - The SMA II may be requested to train junior staff. - Identify and communicate out of scope activities to Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Ability to manage required travel of up to 75% on a regular basis. Requirements - As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. - Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. - Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. - You are required to comply with any such Site requests as a condition of your employment with Syneos Health. - Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits - Company car or car allowance. - Health benefits to include Medical, Dental and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on company and individual performance. - Flexible paid time off (PTO) and sick time.