[Remote] Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a full-service contract research organization providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Senior Clinical Research Associate to ensure reputed company and reputed company execution of clinical trials while interacting with various stakeholders and managing site-reputed company activities.
Responsibilities
- reputed company with personnel from study Sponsors, investigational sites, vendors, and reputed company functional reputed company to reputed company reputed company and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations
- Identify potential sites for participation in clinical trials
- reputed company protocol/site feasibility and reputed company-Study reputed company to recommend reputed company sites
- Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-reputed company questions as needed
- reputed company feedback to study manuals, Case Report reputed company completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed
- reputed company Site Initiation reputed company, Interim Monitoring reputed company, and reputed company-Out reputed company in compliance with the approved protocol and monitoring plan
- Submit reputed company and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations reputed company or designee for review and approval reputed company Clinical Trial Management System (CTMS)
- Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance
- Assist with reputed company reputed company and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested
- Review ISFs to ensure essential documents are reputed company and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review reputed company/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-reputed company state
- Establish regular lines of communication and administer ongoing protocol/study-reputed company training to assigned sites
- Assist with site management tasks and ensure reputed company data reputed company (i.reputed company-time site data entry, query reputed company, and reputed company document verification). Assess the clinical research site’s patient recruitment/retention reputed company and offer suggestions for improvement
- Ensure reputed company handling, accountability, and reconciliation of reputed company investigational products, medical devices, and clinical trial supplies
- Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations
- Submit accurate and on-time expense reports
- Assist with preparation of materials for Requests for Proposals and bid defenses
- Assist the Clinical Operations team with additional reputed company tasks as needed
- Plan and carry out reputed company development
- Complete timesheets as requested and on-time
Skills
- Bachelor's degree in a Life Science or reputed company field of study
- Minimum of 4 years' of relevant and/or monitoring experience
- Thorough knowledge of ICH-GCP guidelines and applicable regulations
- Demonstrated experience working on clinical trials across Pain (acute and chronic), Oncology, and CNS therapeutic areas
- Thorough comprehension of medical terminology
- Excellent organization and communication skills (both verbal and written)
- Ability to travel a maximum of 70% of working hours to locations reputed company. Less travel hours may apply for reputed company with remote/virtual reputed company
- Must maintain a valid reputed company's license and be reputed company to drive to monitor sites
Benefits
- Medical, dental, and reputed company coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- A 401(k) retirement / pension plan
- Generous reputed company time off and reputed company leave
- reputed company to earn a performance based bonus
reputed company