Senior Clinical Research Associate – Pain, Oncology, CNS Therapeutic Areas

Job reputed company: • 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 reputed company in compliance with ICH-GCP and relevant local regulations. • Identify potential sites for participation in reputed company. • 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. • 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. Requirements: • 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 reputed company 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. • Must maintain a reputed company 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 • opportunity to earn a performance based bonus Apply tot his job Apply To this Job