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

• Assisting project managers in the planning, execution, and monitoring of clinical trials. • Coordinating study activities, including site selection, patient recruitment, and data collection. • Supporting the development of study protocols, case report forms, and other study-related documents. • Participating in data analysis and interpretation to support decision-making and regulatory submissions. • Collaborating with cross-functional teams to ensure project milestones are met and deliverables are achieved.

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.  At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.   Currently, we at Rho are seeking a Senior Biostatistician for our Federal Research Team to work 100% remote on a permanent basis.  As a Senior Biostatistician, you will have the opportunity to lead statistical analysis activities for clinical research projects, maintaining a steady, open dialogue regarding study execution as it relates to timelines, data quality, and interpretation of the results.  Rho's team-oriented environment requires you to have open communication skills and the ability to collaborate closely as a member of a cross-functional study team. Rho's high quality standards require careful attention to accuracy and details. Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.   Why Rho? - The foundation of our organization was built on Biometrics, and it continues to be a thriving focal point for our business with strong employee tenure and stability. - We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career! - Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here - It’s fun and vibrant – our culture is unbeatable - Great benefits, time off and 2 promotion cycles per year! - Lastly, we do great work and our studies are properly staffed, that makes for very happy people! These are just some of the reasons Rho has consistently been thought of as one of the CRO industry's best places to work for the past 38 years! Our Biometrics team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!    - Function as statistical lead on complex clinical trials, from development through closeout. - Design scientifically sound clinical research projects, demonstrating understanding of all key design components (e.g., defining study objectives, study design and plan, study populations, treatment regimens as well as determining sample size requirements). - Author statistical sections of study documents (e.g. protocols and SAPs). - Perform various types of statistical analyses of clinical research data (e.g., demographic and other baseline characteristics, measurements of treatment compliance, efficacy evaluation, safety evaluation, pharmacokinetic evaluation, and interim analysis). - Utilize statistical software programs (e.g., SAS, R) to implement advanced statistical methodologies (e.g., longitudinal data analysis, survival analysis, Poisson regression, imputation methodologies and analyses with missing data) and verify underlying distributional assumptions. - Lead the creation of data documentation components of TMFs and regulatory submissions. - Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research projects and make strategic decisions and recommendations accordingly. - Communicate analysis results and relevance to sponsor or investigators. - Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management. - Exhibit the expertise to do tasks independently and to oversee, train and mentor others in task completion. - Participate in the Biostatistics community at Rho by contributing to internal initiatives and standard operating procedures for the administration and support of clinical trials. - Involvement with budgets, proposals, and other business development activities. - Create integrated databases for submission to regulatory bodies. - Represent sponsors at FDA meetings (type A, B, and C). - Respond to information requests or other queries from regulatory bodies. - Author relevant sections of briefing books and briefing packages to support FDA interactions. - Advise and consult with sponsors regarding FDA data analytical and filing requirements.

Clinical Research Physician ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Job Advert Posting At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry Clinical Research Physician - Provide medical data review support to ICON Project Teams in order to ensure that projects of all phases (1-4) are conducted according to the highest ethical principles and medical standards, in accordance with good pharmacovigilance practices and in compliance with applicable legal and regulatory standards. - Provide medical leadership on projects, when assigned. JOB FUNCTIONS/RESPONSIBILITIES: - Serve as medical team leader on assigned projects, - Ensure provision of all contracted activities and identification of out of scope activities on projects assigned - Medical review of clinical trial data, including review of Laboratory alerts, Electrocardiogram (ECG) alerts, data from eCRF/ EDC (listing review/ Patient profile review), Eligibility review, Identify protocol deviations, coding review and preparation of Medical Monitoring Reports as per requirement - Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: - Medical information source - Ongoing training for project teams in therapeutic areas as requested - Review of study documentation (protocol, CRF. etc.) - Contribute to investigator meeting presentations - Ongoing safety review of individual patient laboratory reports generated by central laboratories - CRF safety review - Contribute any necessary medical input into integrated clinical and statistical reports - Assist in making presentations to potential clients when appropriate - Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs - Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations - Represent ICON Medical Affairs at teleconferences and meetings - Liaise with Sponsors regarding medical issues and medical consultation - Ensure quality of medical deliverables in accordance with project plans and ICON Standards - Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention QUALIFICATIONS/EXPERIENCE REQUIRED: - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions - Medical degree and broad based post graduate clinical experience - Preferably 1-2 years’ experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills - Proficiency in English, Good oral and written communication skills - Ability and willingness to travel on an as-need basis - Excellent presentation skills - Good computer skills (MS: Outlook, Word, Excel) Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. #LI-CL1 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply