clinical research Associate ii, iii, sr. clinical research AssociateNovotech

Clinical Operations · Manila, Philippines
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Department Clinical Operations
Employment Type Full Time
Minimum Experience Experienced
#LI-TM01
About Novotech
Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.
Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas.
Our people are critical in meeting organizational, and client objectives and we place a strong emphasis on creating a collaborative, transparent, and inclusive work environment where everyone is supported to achieve.
Brief Position Description:
The Clinical Research Associate III and Sr. Clinical Research Associate will be 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.
As an experienced CRA, they provide mentorship to junior staff and can also provide support to the project manager in the role of Lead Clinical Research Associate (LCRA).
Minimum Qualifications & Experience:
Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. Preferably with one to three years site monitoring or research experience. Must be computer literate.
Responsibilities:
1. 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. Performs site selection visits unaccompanied, and ensures sites have adequate resources to conduct the study. Advises PM/LCRA on acceptability of potential 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 review, patient eligibility confirmation, protocol compliance including investigational product 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. All completed data queries are required to be verified by the CRA prior to database lock.
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.
2. 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.
3. Ensure any error or omission in study procedure at site is appropriately documented, including an explanation and suggestion to prevent further occurrences.
4. 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.
5. In collaboration with the CTA/ co-ordinate transfer of data and documents between site, Novotech and sponsor, e.g. CRF pages, data queries and essential document transfers as per sponsor requirements.
6. Ensure project tracking systems are updated to reflect work performed at clinical trial site.
7. 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, investigator payments etc. Provide updates on study progress to CRA/PM as required by the PM/LCRA.
9. Assist with CRA training programs in the development and delivery of training programs/workshops in conjunction with Learning and Development Manager and
serve as mentor to CRAs/CTAs.
10. Provide general clinical support to the clinical project teams according to the needs of the Novotech Clinical Operations Department.
11. Assume project management responsibilities, where appropriate, under the supervision of a Novotech Project Manager and Line Manager.
12. Maintain an awareness of the assigned therapeutic area, including an understanding of the investigational product and its actions, and commercial value. Have a good
understanding of clinical trial design and drug development process.
13. Demonstrate a thorough understanding of ICH GCP, the Declaration of Helsinki and local guidelines, along with local and international regulatory regulations according to the specific clinical trial. Be able to provide direction to international clients of local and national requirements. Represent the views/needs of local sites to global protocol development and implementation.
14. Be aware of and adhere to company process in areas relevant to a SCRA. Be quality focused in performance of duties. Assist in the review and development of clinical
SOPs and processes.
15. Participate in activities of the Clinical Operations department, including presentation at clinical department meetings, assist with development of clinical process and
SOPs. Identify areas of inefficiency in process, and make recommendation for improvements.
16. In collaboration with Business Development (BD), provide feasibility information, as requested and in accordance with documented feasibility processes. Highlight any BD opportunities to the group.
17. 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.
18. 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.
Find out more about working at Novotech at:
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.
Novotech

Manila City, Metro Manila
Permanent
Full-time