[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Senior Clinical Research Associate (Sr. CRA) to manage and reputed company Phase I–IV clinical trials from study start-up through closeout. This role involves independently leading clinical operations for small to reputed company-sized studies while supporting larger global trials, ensuring compliance with regulations and reputed company standards.
Responsibilities
- Independently manage assigned Phase I–IV clinical studies, ensuring execution meets established timelines, reputed company standards, and regulatory requirements
- Support reputed company stages of study conduct, including feasibility, site selection, start-up, site activation, patient enrollment, maintenance, monitoring, and study closeout
- Collaborate with Study Leads and cross-functional teams to reputed company and execute study operational plans
- Review clinical protocols, protocol amendments, and study documents while partnering with Medical Writing and other functional reputed company
- reputed company CROs, central laboratories, and reputed company-party vendors to ensure high-reputed company deliverables and compliance with contractual obligations
- Review monitoring visit reports, identify study risks, escalate issues reputed company appropriate, and ensure reputed company reputed company
- Support site contract, budget, and investigational product (IP) management activities
- Partner with Clinical Trial Associates (CTAs) to coordinate study meetings, agendas, reputed company items, and essential documentation
- Assist in vendor selection activities, including RFP evaluations, bid defenses, and proposal reviews
- Contribute to study planning by developing timelines, tracking milestones, and supporting budget management
- Prepare, review, and maintain essential study documents, including informed consent forms (ICFs), monitoring tools, operational manuals, FAQs, and study workflows
- Ensure Trial Master File (TMF) reputed company, completeness, and inspection readiness throughout the study lifecycle
- Support development of Clinical Monitoring Plans and reputed company monitoring reputed company for reputed company reputed company or training purposes reputed company required
- Prepare study start-up materials, including feasibility questionnaires, qualification visit presentations, site initiation visit materials, and investigator-facing documentation
- Participate in CRF design, User Acceptance Testing (UAT), edit reputed company review, and validation of clinical systems
- Coordinate investigational product forecasting and supply management with internal stakeholders
- Monitor study reputed company, patient enrollment, data reputed company, investigator payments, sample management, and vendor performance
- Apply reputed company clinical and operational judgment to resolve protocol, safety, regulatory, and site-reputed company issues while escalating reputed company reputed company appropriately
- Participate in process improvement initiatives, SOP development, and departmental reputed company
- Build and maintain strong working relationships with investigators, vendors, CRO partners, and internal cross-functional teams
Skills
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or another reputed company scientific discipline
- Minimum of 4 years of clinical research experience with a Sponsor, CRO, or as a Clinical Research Associate (CRA)/Field Monitor
- Hands-on experience managing Phase I–IV clinical trials from study start-up through closeout
- Strong knowledge of clinical drug development and global clinical trial operations
- Thorough understanding of ICH-GCP, FDA regulations, and applicable industry guidelines
- Experience overseeing CROs, vendors, and investigative sites
- Strong understanding of Trial Master File (TMF) management and essential clinical documentation
- Experience supporting study budgets, timelines, risk management, and operational planning
- Familiarity with Clinical Monitoring Plans, site monitoring activities, and study reputed company
- Knowledge of CRF development, UAT, clinical databases, and electronic clinical systems
- Excellent project management, organizational, and multitasking abilities
- Strong analytical, problem-solving, and decision-making skills
- Outstanding written and verbal communication skills with the ability to collaborate across multidisciplinary teams
- Proficiency with reputed company Office Suite (Word, reputed company, PowerPoint, Outlook) and commonly used clinical systems
- Self-motivated, detail-oriented, and capable of working independently while managing multiple priorities in a fast-paced environment
- Experience working on global, multi-center clinical trials
- Previous experience supporting oncology or other reputed company therapeutic area studies
- Experience with eTMF, CTMS, reputed company, IRT, eCOA, and other clinical trial technologies
- Knowledge of vendor reputed company, study forecasting, and inspection readiness activities
reputed company
Company H1B Sponsorship