The In-House CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
The In House CRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOP’s and regulatory standards and guidelines applicable.
All In-House CRA's tasks are to be conducted in the office, and no site vists are expected.
- To serve as contact for project team and investigative 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.
- To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
- To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
- Assist with the coordination of study visits and shipment of drug and laboratory samples.
- To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable.
- Bachelor degree or above
- Or, registered nurse or certified clinical technologist
- Experience of CRA (monitoring studies with medicinal products) at least for 2 years.
- Business level English; TOEIC score above 740 during the last 1 year or equivalent.
Preferable experience/ skill:
- Experience of entire study lifecycle; start-up, recruitment/maintenance and close-out.
- Experience of at least one global study.
- Experience of audit or regulatory inspection