Premier Research is looking for a CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast) to join our Clinical Monitoring and Site Management 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:Conducts all monitoring visit types (qualification, initiation, interim, close-out; ) per the Clinical Monitoring Plan, ensuring data integrity, patient safety, and quality/timeliness of deliverables and reports, while planning and prioritizing day-to-day site activitiesEnsures validity, correctness, and completeness of clinical data per ICH GCP/ISO14155, protocol, and client requirements; manages query resolution with sites and Data ManagementMaintains TMF/eTMF per ICH/GCP Appendix C and organizational filing guidelines, reviewing site documents for accuracy and completeness; reviews IP accountability and logs as directedManages communication with study sites, project teams, and management, including Investigators' Meetings and required internal/study-specific training and therapeutic knowledge-buildingHandles administrative responsibilities: timely expense submission, time/hours entry, project tracking, site visit metrics, and confidentiality/compliance with global and local lawsProactively supports the project: reduces backlog, assesses feasibility/recruitment as needed, acts as a resource/SME for other CRAs, may take on additional country- or project-specific responsibilities, and performs other duties as assignedWhat We Are Searching For:Undergraduate degree or its international equivalent ence, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required2+ years’ experience in clinical trials and proven previous success as a CRA required, completion of CRA training programStrong regulatory/clinical knowledge: ICH/GCP, FDA/EU/local regulations, ISO14155, drug/device development, and clinical monitoring procedures, plus relevant clinical/health systems and cultural/regional knowledge for assigned marketsProven leadership and collaboration: experience coaching/mentoring CRAs, strong team player, full-time availability to internal/external stakeholders, and global experience preferredSelf-directed and organized: excellent time-management skills, self-starter with sound judgment, able to multitask and adapt in a fast-paced, changing environmentAccountable and customer-focused: dependable with strong commitment, applies consistent performance standards, decisive problem-solver, and customer-service oriented internally and externallyTravel: 70-85%Lifting up to 25lbsValid driver’s license, passport as requiredExperience required e Disease, Neurology, or DermatologyTo be considered for this position, you must be located in one of the following regions: West Coast, Midwest, Northeast.Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $75,000 USD. 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. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
3 months ago