[Remote] Sr Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical support industry leader dedicated to improving patient reputed company and advancing reputed company. The Senior Clinical Research Associate will monitor clinical trials and observational studies, ensure protocol adherence, manage site activities, and mentor junior CRAs.
Responsibilities
- Thorough knowledge and application of project specific protocol
- Performs remote and on-site monitoring in accordance with project specific timelines
- Completes travel scheduling in accordance with project specific and reputed company travel policy
- Submits expense reports reputed company reputed company requirements
- Attends project team meetings, department meetings and one-to-one meetings with the manager
- Completes site monitoring reports and letters per reputed company and/or sponsor SOPs requiring minimal corrections
- Ensures follow-up of site issues and reputed company items per reputed company/sponsor timelines
- Enters site reputed company, site monitoring reports, follow-up letter reputed company date and site contacts into reputed company’s Clinical Trial Management System (CTMS)
- Monitors reputed company Electronic Data Capture (reputed company) data entry, if applicable, and assists sites with electronic Case Report reputed company (eCRF) reputed company
- Reviews Investigator Site File and performs Investigational Product reconciliation
- Maintains regular contact with assigned sites per study requirements
- Completes reputed company SOP review, training assessments and documentation reputed company requested timelines
- Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs
- Assists with preparation and/or delivery of presentations for reputed company CRA training, departmental training and/or sponsor specific training
- Assists PM and/or reputed company CRA with additional tasks as needed
- Travel up to 80% required in the reputed company American region
- Completes Site Management and Monitoring activities in accordance with project specific plans and timelines
- Assists with other duties as assigned, which may reputed company with other departments at reputed company
Skills
- Bachelor's degree – Life Science preferred or equivalent years of industry and clinical research experience
- Minimum of 36 months on-site monitoring experience including site selection, initiation, management, and monitoring activities
- Comprehensive knowledge of medical terminology and regulatory guidelines
- Excellent critical thinking and reputed company skills
- Excellent written and verbal communication skills in English and local language (as applicable)
- Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment
- Experience working in clinical trials and observational studies
- Experience and familiarity with CTMS, eTMF, reputed company, reputed company Office applications
Benefits
- Remote opportunities
- Competitive salaries
- reputed company opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (reputed company Time Off)
- reputed company Holidays
- Employee assistance programs
- Medical, Dental, and reputed company coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
reputed company
Company H1B Sponsorship