[Remote] Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas)

Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research 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 quality and timely execution of clinical trials while interacting with various stakeholders and managing site-related activities.ResponsibilitiesInteract with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulationsIdentify potential sites for participation in clinical trialsPerform protocol/site feasibility and Pre-Study Visits to recommend qualified sitesParticipate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as neededProvide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as neededPerform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring planSubmit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via 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 complianceAssist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requestedReview ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready stateEstablish regular lines of communication and administer ongoing protocol/study-related training to assigned sitesAssist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site’s patient recruitment/retention success and offer suggestions for improvementEnsure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial suppliesPrepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research OrganizationsSubmit accurate and on-time expense reportsAssist with preparation of materials for Requests for Proposals and bid defensesAssist the Clinical Operations team with additional related tasks as neededPlan and carry out professional developmentComplete timesheets as requested and on-timeSkillsBachelor's degree in a Life Science or related field of studyMinimum of 4 years' of relevant and/or monitoring experienceThorough knowledge of ICH-GCP guidelines and applicable regulationsDemonstrated experience working on clinical trials across Pain (acute and chronic), Oncology, and CNS therapeutic areasThorough comprehension of medical terminologyExcellent organization and communication skills (both verbal and written)Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visitsMust maintain a valid driver's license and be able to drive to monitor sitesBenefitsMedical, dental, and vision coverageLife & AD&D insuranceShort- and long-term disabilityTuition reimbursementFitness reimbursementEmployee assistance program (EAP)A 401(k) retirement / pension planGenerous paid time off and sick leaveThe opportunity to earn a performance based bonusCompany OverviewEverest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields It was founded in 2004, and is headquartered in Markham, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://www.ecrscorp.com/.