inhouse clinical research AssociateNovotech

Clinical Operations · Manila, Philippines
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Department Clinical Operations
Employment Type Full Time
Minimum Experience Mid-level
#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 Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.
Minimum Qualifications & Experience:
Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
IHCRA
Entry to less than 2 years' experience as inhouse CRA or relevant roles
Senior IHCRA
At least 2-3 years' experience in inhouse CRA or relevant roles
Responsibilities:
Support the clinical team's inhouse activities on assigned projects.
Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
Create the Investigator Site Files, coordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
May Assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. Prepare and amend the CTA within agreed negotiation parameters and policies. Work closely with the Project Management, Clinical Operations and Legal teams to facilitate timely execution of CTA.
Prepare and update site Subject Visit Template (SVT)'s in accordance with site budgets.
Take a responsibility of submission and tracking of Investigator payments in CTMS and any finance system. Complete study finance reconciliation as requested by the CRA, ensuring subjects activities are updated.
Assist with vendor management updates, tracking and payments as requested by the CRA including updating laboratory normal reference ranges. As required also support sourcing supplies, shipment arrangement and customs clearance.
As required, may contact site staff/Investigators on behalf of the CRA to request information or resolve issues.
Take a responsibility of document archiving as per Novotech SOPs.
Where required, track and report study SUSARs/CIOMS to the relevant stakeholders, i.e. Regulatory Authorities, Investigators and Sponsors according to the Safety Management Plan and Clinical Monitoring Plan. of Novotech ambassador when carrying out Inhouse Clinical Research Associate role.
Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
Be aware of and adhere to company processes in areas relevant to an Inhouse Clinical Research Associate. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role.
In addition to core activities as senior IHCRA,
May provide in-house support for Regional Lead CRAs on large regional projects
Act as a mentor to new team members and to any temporary staff who are employed on an ad hoc basis
Assist with training for the team and be prepared to offer written feedback on performance as part of the Novotech appraisal process.
May take on a Systems Super User role such as CTMS as required by the needs of the Clinical Operations department.
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