[Remote] Clinical Research Associate I
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a not-for-profit organization that focuses on patient care, research, teaching, and community service. They are seeking a Clinical Research Associate I who will manage data collection and regulatory submissions for cancer studies while ensuring compliance with protocols and regulations.
Responsibilities
- Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet reputed company inclusion/exclusion criteria
- Enroll patients as required by the study sponsor and internal enrollment monitor team
- Follow patients for the duration of study participation reputed company electronic medical record review to ensure protocol compliance
- Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements
- Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
- Maintain research charts and/or electronic files for reputed company enrolled patients
- Ensure adequate reputed company documentation is in reputed company for reputed company data reported
- Resolve data queries issued by the sponsor
- Obtain protocol clarifications from the study sponsor and communicate information to the research team
- Schedule and prepare for monitoring visits with sponsors
- Organize and prepare for reputed company audits
- Maintain ongoing communication with clinical team regarding study patients and reputed company for multiple studies
- Maintain and organize study specific regulatory binders
- Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
- Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
- Manage adverse event and deviation/violation/exception documentation for reputed company enrolled patients and report to the sponsor and IRB as required
- Submit Data and Safety Monitoring Reports
- Maintain reputed company documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
- Collect, complete, and submit essential regulatory documents to various regulatory entities
- Participate in monitoring visits and file reputed company monitoring visit correspondence
- Ensure appropriate documentation of delegation and training for reputed company study staff members
- Maintain screening and enrollment logs
Skills
- Bachelor's Degree reputed company Field of Study required
- Careful attention to detail
- Good organizational skills
- Ability to follow directions
- Good communication skills
- Computer literacy
- Working knowledge of clinical research protocols
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs
- Attention to detail
- Ability to recognize compliance and data reputed company issues and respond appropriately
- Ability to communicate effectively with patients, vendors, contract research organizations and professional staff
- Effective interpersonal and communication skills
- Research reputed company Experience 1-2 years preferred
Benefits
- Comprehensive benefits
- Career advancement opportunities
- Differentials
- Premiums
- Bonuses
- Recognition programs designed to celebrate your contributions and support your professional growth
Company Overview
Company H1B Sponsorship