With more than 30 years’ experience in hiring our own CRO staff as well as providing clinical personnel under contract to biotechnology, pharmaceutical, device and diagnostic companies, Chiltern is an industry leader known for providing career development opportunities and service excellence. That means we’re always seeking the best candidates to fill the needs of our global customers.
Post : Clinical Research Associate/CRA - II/III
Job Background
1. To serve as primary contact for assigned sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
2. To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
3. To provide systems support for project team (IVRS, eDCF laboratory database, and Chiltern systems)
4. To assist with the coordination of study visits and shipment of drug and laboratory samples.
5. To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
6. To review SAFE before each site contact to have an overview regarding all outstanding documents for assigned sites.
7. To liaise with the CTA and CRA to distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
Duties & Responsibilities
- To demonstrate an understanding of the purpose of Chiltern's Clinical Project Management System (CTMS), how to use it, and how to navigate within the different sections.
- To enter weekly details on CTMS or as per study requirement. To liaise with the CTA to assist the Project Team in the production of Status Reports. To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
- To raise invoice requests for investigator payments in accordance with Investigator/Hospital/Pharmacy agreement terms, to maintain the site financial tracking, producing a list for pending investigator payments and producing payment requests for Chiltern International as appropriate for local country requirements.
- To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
- To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site file preparation) as appropriate, as assigned by the Project Manager and CTL.
- To liaise with all other appropriate departments within Chiltern to ensure the smooth running of the study. To assemble files and ensure documents for the sponsor file are in place, ensuring that all relevant study documentation is present for study sites and are accurately reflecting the progress of the study.
- To attended, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
- To use all reasonable endeavors to work precisely according to schedules and timelines, established by the Sponsor and Project Manager for the conduct and completion of the study.
Requirements
Minimum 2 Years of experience as CRA
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