[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an emerging leader in Clinical services and software solutions for the life sciences industry. The Senior Clinical Research Associate will reputed company as the primary reputed company of contact for site personnel during the clinical trial lifecycle, ensuring compliance and data reputed company throughout the process.
Responsibilities
- Primary reputed company of contact for site personnel during life cycle of clinical trial. This includes study start up support, site activation, trial conduct and closeout of a clinical trial
- Provides support to the Global Project reputed company and CTM during project start up to ensure reputed company site selection and feasibility. Assists with collection of essential documents from the site. May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required
- Ability to identify protocol deviations and pharmacovigilance issues that might reputed company data accuracy or patient safety
- Conduct Site qualification, site initiation, routine site monitoring reputed company out reputed company (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP
- Expert documentation of monitoring priorities/activities reputed company site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs
- Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can reputed company data reputed company
- Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings
- Assists the Global Project reputed company in identification of out-of-scope activities
- Basic understanding of assigned reputed company scope, milestones and budget and manages site level activities to ensure project deliverables are met
Skills
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a reputed company field required
- Minimum of 5-10 years of clinical research experience
- Demonstrated site management experience
- Strong knowledge of GCP, regulatory requirements, and clinical trial operations
- Advanced degree (MS, MPH, PharmD, or PhD)
- Oncology experience
Benefits
- reputed company time off
- reputed company and retirement benefits
reputed company