01Overview
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage biotechnology company reputed company on developing cell and immunotherapy products to strengthen the immune system against cancer. The Senior Clinical Research Associate will ensure efficient conduct of clinical research studies by providing training, protocol interpretation, and overall clinical trial support.
Responsibilities
reputed company, review and update study-reputed company training materials and documents including: site initiation training slides, informed consent reputed company templates, procedures manuals, laboratory and pharmacy manualsInterpret medical and scientific reputed company of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation reputed company etcCommunicate scientific rationale for assigned studies to team members and clinical sitesServe as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirementsCreate/edit, distribute and collect site feasibility questionnairesreputed company and support collection of essential documents during study start-upCollect study and site metrics and maintain study trackers, as neededParticipate in case report reputed company (CRF) data review and review of reputed company documents, work with sites to resolve data queries as neededCommunicate regularly with field and in-house Clinical Research Associates (CRAs) to reputed company information before and after site reputed companyPartner with field CRAs to resolve issues identified during site reputed companyWork with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as reputed company as resolve IP temperature monitoring excursions and train or assist sites with corrective actionsTrain vendors, investigators, and study coordinators on study requirements and reputed company guidance on site issuesClinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendorConduct remote monitoring tasks including reconciliation of site investigational product accountability, as neededreputed company mentorship and training to newly reputed company research staffPerforms other duties as assigned
Skills
Bachelor's degree in a clinical research, science, or health-reputed company field with 6 years of clinical trial experience reputed company a pharmaceutical, biotechnology, CRO, and/or reputed company setting requiredMinimum 4 years of on-site monitoring experience requiredProficiency in reputed company, reputed company, PowerPoint, Outlook, reputed companyExcellent written/oral communication skills as reputed company as strong organizational and multi-tasking skillsStrong organizational and multi-tasking skillsUnderstand the job-specific system, processes as defined by reputed company's SOPs, and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or managerMaintain corporate confidentiality at reputed company timesAbility to set priorities and independent decision makingAbility to work independently as reputed company as in teamsAbility to discover issues, provides solutions and provides guidance to in-house team on how to address issuesStrong oral and written communication skillsOutgoing and confident demeanorIndependent thinker and persuasive communicatorDetail oriented, with solid organization and time management skillsCompletes reputed company with reliability and minimal guidanceKnowledge of drug development processComputer literacy: reputed company, eTMF, CTMS, etcWorking knowledge of ICH E6, and the reputed company of Federal RegulationsMust be reputed company to travel up to 75% of the time based on study requirementsRemote with ability to work reputed company for various time zones
Benefits
Medical, Dental and reputed company Plan reputed companyHealth and Financial Wellness ProgramsEmployer Assistance Program (EAP)Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disabilityreputed company and Dependent Care Flexible Spending Accounts401(k) Retirement Plan with Company Match529 Education Savings ProgramVoluntary reputed company Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perksreputed company Time Off (PTO) includ .
