Senior Clinical Research Associate
New
J
JobgetherClinical Research
Based in United StatesFull-TimeSenior
SalaryCompetitive compensation package, including eligibility for a sign-on bonus of up to $10,000.
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 1 year of clinical trial monitoring experience
- Required Skills
- Data management
Requirements
- Minimum of 1 year of clinical trial monitoring experience or equivalent relevant experience.
- Bachelor’s degree or higher in a healthcare-related discipline or equivalent clinical experience.
- Registered Nurse (RN) qualification with relevant clinical experience, or equivalent professional background.
- Previous experience conducting clinical research studies within a hospital, pharmaceutical company, or Contract Research Organization (CRO) environment.
- Demonstrated experience performing site monitoring activities, preferably with at least one year of on-site monitoring experience.
- Strong understanding of clinical research processes, ICH-GCP guidelines, regulatory requirements, and SOP compliance.
- Excellent organizational skills with the ability to manage multiple priorities, timelines, and study requirements.
- Strong written and verbal communication skills with the ability to collaborate effectively with investigators, sponsors, and internal teams.
- Ability to identify issues, apply sound judgment, and implement solutions in a clinical research environment.
- Proficiency with clinical trial systems, documentation tools, and standard office applications.
Responsibilities
- Serve as the primary contact for assigned clinical study sites and maintain strong relationships with investigators and site teams.
- Conduct monitoring visits, including pre-study visits, site initiation visits, interim monitoring visits, and close-out visits, ensuring compliance with monitoring plans, SOPs, and ICH-GCP guidelines.
- Support study start-up activities, including feasibility assessments, site selection, regulatory documentation, and site activation processes.
- Review, collect, and maintain essential regulatory documents, investigator site files, and trial master files according to applicable procedures.
- Monitor patient enrollment activities and support site-specific strategies to improve recruitment and retention.
- Ensure proper handling, storage, accountability, and documentation of investigational products and trial materials.
- Perform remote monitoring activities and use clinical trial systems and reports to track study progress, data quality, documentation status, and compliance.
- Identify site performance issues, implement corrective actions, and escalate risks when necessary.
View Full Description & ApplyYou'll be redirected to the employer's site
