Clinical Research Associate

2 weeks ago

Bengaluru, India Novotech Asia Full time

**About the position**

The Clinical Research Associate 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.

**Core Responsibilities**

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) 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. Participate in Investigator Meetings as appropriate, including preparing and presenting presentations.
- ** 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 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 checks, 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 and 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.
- ** Close out & archiving**: Conduct site close out visit, and ensure all study issues are resolved, 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.

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