Job title: Clinical Research Associate III
Company: Novo Tech
Job description: About the position The Clinical Research Associate III is responsible for ensuring the rights and wellbeingof trial participants are protected and the reported trial data are accurate, complete andverifiable from source documents.The CRA III is also
About the position The Clinical Research Associate III is responsible for ensuring the rights and wellbeingof trial participants are protected and the reported trial data are accurate, complete andverifiable from source documents.The CRA III is also the primary link betweenInvestigational Sites and Sponsor, acting as a site manager ensuring that clinical trials areconducted and documented as per ICH GCP guidelines, local and global regulatoryrequirements and Novotech/Client SOPs. Core Responsibilities Monitoring of investigational sites as per ICH GCP 5.18 (Monitoring) and theClinical Monitoring Plan for each study. Specific duties include: Site Selection:Assist Project Manager (PM) with identification, site feasibilities,and selection of investigational sites. Ethics & Regulatory Submission:In collaboration with the CTA and Novotech’sRegulatory Operations Group, prepare site essential documents, and participate inthe ethics and regulatory submission and approval processes. Study Initiation:Train investigators on the sponsor and regulatory requirementsfor conducting the study. Ensure the site has all supplies to perform the trial.Participate in Investigator Meetings as appropriate, including preparing andpresenting presentations. Recruitment:Ensure recruitment of participants as per the site target. Takepositive action to encourage site recruitment, and report recruitment issuespromptly to the PM/LCRA. Prepare site specific recruitment plan(s) asappropriate and update as required. Monitoring Visits:Perform visits to site according to the Clinical MonitoringPlan.Ensure the trial is conducted according to the protocol, ICH GCP, any localguidelines & local/global regulatory requirements. Patient Safety:Ensure rights & wellbeing of trial participants are protected,including consent form checks, patient eligibility confirmation, protocolcompliance including investigational drug compliance, and review of AdverseEvents/SAEs. Ensure safety issues are reported to the sponsor promptly. Data Collection:Verify trial data are accurate and complete, ensure CRF data arecompleted correctly and transmitted to the client as per the study timelinesdocumented in the Clinical Monitoring Plan. Ensure data queries are completedappropriately and promptly by site staff. Site Documentation:Review site files and ensure all documentation is present andcomplete. Investigational Material:Ensure all study drug is appropriately stored, dispensed,accounted for and reconciled as per the Clinical Monitoring Plan and theProtocol. Investigator Advocate:Represent the views of the Investigator to the sponsor (viaPM), including contractual/budget negotiations. Close out & archiving:Conduct site close out visit, and ensure all study issues areresolved, including reconciliation and disposition of the investigational product.Ensure sites understand archiving responsibilities. Minimum Qualifications & Experience: Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered Preferably at least 2 years site monitoring or research experience Must be computer literate Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. For more information about where your next career step at Novotech might take you, visit http://novotech-cro.com/novotech-careers.
Expected salary:
Location: Bangalore, Karnataka
Job date: Wed, 22 Jun 2022 22:14:30 GMT
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