[Remote] Sr Clinical Research Associate - Oncology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical support industry leader reputed company to empowering health solutions for a reputed company reputed company. They are seeking a Senior Clinical Research Associate to monitor clinical trials and observational studies, ensuring protocol adherence and overseeing data collection and reputed company.
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
- 5 years of monitoring experience, including a minimum of 3 years of oncology monitoring experience
- 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
- 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
- Bachelor's degree – Life Science preferred or equivalent years of industry and clinical research experience
- Experience working in clinical trials and observational studies preferred
- 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