Note: The job is a remote job and is open to candidates in USA. Spark Life Solutions Inc is seeking an experienced Senior Clinical Research Associate (Sr. CRA) to manage and oversee Phase I–IV clinical trials from study start-up through closeout. This role involves independently leading clinical operations for small to medium-sized studies while supporting larger global trials, ensuring compliance with regulations and quality standards.
Responsibilities
- Independently manage assigned Phase I–IV clinical studies, ensuring execution meets established timelines, quality standards, and regulatory requirements
- Support all 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 develop and execute study operational plans
- Review clinical protocols, protocol amendments, and study documents while partnering with Medical Writing and other functional groups
- Oversee CROs, central laboratories, and third-party vendors to ensure high-quality deliverables and compliance with contractual obligations
- Review monitoring visit reports, identify study risks, escalate issues when appropriate, and ensure timely resolution
- Support site contract, budget, and investigational product (IP) management activities
- Partner with Clinical Trial Associates (CTAs) to coordinate study meetings, agendas, action 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) quality, completeness, and inspection readiness throughout the study lifecycle
- Support development of Clinical Monitoring Plans and perform monitoring visits for quality oversight or training purposes when 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 check review, and validation of clinical systems
- Coordinate investigational product forecasting and supply management with internal stakeholders
- Monitor study progress, patient enrollment, data quality, investigator payments, sample management, and vendor performance
- Apply sound clinical and operational judgment to resolve protocol, safety, regulatory, and site-related issues while escalating complex matters appropriately
- Participate in process improvement initiatives, SOP development, and departmental projects
- 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 related 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 oversight
- 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 Microsoft Office Suite (Word, Excel, 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 complex therapeutic area studies
- Experience with eTMF, CTMS, EDC, IRT, eCOA, and other clinical trial technologies
- Knowledge of vendor oversight, study forecasting, and inspection readiness activities
Company Overview
Company H1B Sponsorship