Novotech Clinical Research Associate Job For Life Sciences
Novotech Clinical Research Associate Job For Life Sciences. Life Science candidates apply for a clinical research associate vacancy. Interested and eligible applicants can check out all of the details on the same below.
About the position:
The Clinical Research Associate II/III is responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete and verifiable from source documents. The CRA is also the primary link between Investigational Sites and Sponsor, acting as a site manager ensuring that clinical trials are conducted and documented, as per ICH GCP guidelines, local and global regulatory requirements and Novotech/Client SOPs.
- Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan for each study. Specific duties include:
- Site Selection: Assist Project Manager (PM)/LCRA with identification, site feasibilities, and selection of investigational sites.
- Ethics & Regulatory Submission: In collaboration with the CTA and Novotech’s Regulatory Operations Group, prepare site essential documents, and participate in the ethics and regulatory submission and approval processes.
- Study Initiation: Train investigators on the sponsor and regulatory requirements for conducting the study. Ensure the site has all supplies to perform the trial.
- Recruitment: Ensure recruitment of participants as per the site target. Take positive action to encourage site recruitment, and report recruitment issues promptly to the PM/LCRA. Prepare site-specific recruitment plan(s) as appropriate and update as required.
- Monitoring Visits: Perform visits to the site according to the Clinical Monitoring Plan. Ensure the trial is conducted according to the protocol, ICH GCP, any local guidelines & local/global regulatory requirements.
- Patient Safety: Ensure rights & wellbeing of trial participants are protected, including consent form review, patient eligibility confirmation, protocol compliance including investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
- Data Collection: Verify trial data are accurate and complete, ensure CRF data are completed correctly and transmitted to the client as per the study timelines documented in the Clinical Monitoring Plan. Ensure data queries are completed appropriately and promptly by site staff.
- Site Documentation: Review site files, in house and at the site to ensure all documentation is present and complete.
- Investigational Material: Ensure all study drug is appropriately stored, dispensed, accounted for and reconciled as per the Clinical Monitoring Plan and the Protocol.
- Investigator Advocate: Represent the views of the Investigator to the sponsor (via PM), including contractual/budget negotiations.
- Closeout & archiving: Conduct site closeout visit, and ensure all study issues are resolved, including reconciliation and disposition of the investigational product. Ensure sites understand archiving responsibilities.
- Ensure both site and sponsor have copies of all essential documents as per ICH GCP and global/ local regulatory requirements, and that these are stored appropriately at the clinical trial site.
- Ensure any errors and omissions in study procedures at site are appropriately documented, including an explanation and suggestions to prevent further occurrences.
- Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.
- In collaboration with the CTA, co-ordinate the transfer of data and documents between site, Novotech and sponsor, i.e. CRF pages, data queries and essential document transfers as per sponsor requirements.
- Ensure project tracking systems are updated to reflect work performed at the clinical trial site.
- Assist with the development and update of systems to track study progress as per the PM requirements, i.e. CRF & query flow, safety reports, regulatory documents, contact records etc. Provide updates on study progress to LCRA/PM as required by the CMP/ Communication Plan.
- In collaboration with the PM, co-ordinate the services of sub-contractors to ensure the study is adequately supported, i.e. central laboratory, drug distributors, IVRS/IWRS providers etc.
- Provide general clinical support to the clinical project teams according to the needs of the Novotech Clinical Operations Department.
- Maintain an awareness of the assigned therapeutic area, including an understanding of the investigational product, its actions and commercial value.
- Demonstrate a thorough understanding of ICH GCP, The Declaration of Helsinki, and any local guidelines as they apply to the investigator, sponsor, monitor and IEC.
- Understand the requirements of applicable local regulatory requirements, and a basic understanding of international regulations as relevant to specific clinical trials.
- Be aware of and adhere to company process in areas relevant to a CRA. Be quality focused in performance of duties.
- Participate in activities of the Clinical Operations Department, including a presentation at departmental meetings and assisting with the development of clinical process and SOPs.
- Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings). Be mindful of the role of ambassador for Novotech when conducting day to day business.
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external parties present a positive professional image of the company.
Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Preferably at least 2 -4 years of site monitoring or research experience. Must be computer literate.
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