Company: Pharm-Olam International
Location: seoul, South Korea
Reference: SCRA 1194 _SS_South Korea
Closing Date: 18 Nov 16
Salary (£): Negotiable
, full time Contract home based position in South Korea - To ensure that Investigators are conducting clinical trials in accordance with international as well as National Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).
Site Management & Site Monitoring
Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
Track collection of ongoing study data for purpose of regular project status reporting as required.
Assist clinical management in conducting feasibility assessment for potential studies.
Participate in feasibility and/or site identification activities.
Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
Monitor activities at clinical study sites to assure adherence to ICH-GCP, global and local regulatory requirements, SOPs, and study specific requirements.
Collect and review regulatory documents as required.
Perform site visits for investigator selection, site initiation, interim monitoring and close-out activities.
Prepare site visit and telephone reports.
Responsible for multiple projects and must work both independently and in a team environment.
May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, reviewing developed CRFs, preparing local versions of Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training or project newsletters.
Resolve site issues and determine status for IP shipment.
Work with Project Manager (PM), Clinical Team Leader (CTL) and/or regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
May translate, coordinate translations or review completed translations of critical documents.
Assist the Project Team with the day-to-day management of clinical studies as required.
May be involved in Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
May be required to conduct project co-monitoring, assessment visits and team training.
May be assigned as CTL to a regional or global study.
May be assigned as a reviewer of Essential Document Packages (EDP) as a Clinical Reviewer (CR) or Independent Reviewer (IR).
May liaise with Business Development and make presentations to potential clients.
May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices)
Assist clinical management with compilation of regulatory intelligence for the countries in APAC region.
Provide recommendations on regulatory strategy for submissions and approvals in the country.
Directly or through coordination with vendor(s), ensure regulatory dossier is in compliance with the local regulatory/ ethical requirements, including, but not limited to CTAs, drug labels, subject information sheet and consent forms, etc.
Drive and participate in interactions with regulatory authorities and Sponsors (where needed).
The Brackens, London Road, Ascot, Berkshire
|Tel:||+44 (0) 1344 891121|
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