Demonstrates the ability to define and meet project requirements. Proposes, implements, and evaluates appropriate resolutions. Seeks to understand all contributing factors. Proactively identifies and addresses problems. Mature management skills demonstrated by calm and thorough review of situations. Has shown ability to successfully manage people/project issues. Can demonstrate experience and knowledge in the CRO industry that will support POI's management of clinical trials. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Skills to mentor and train other CRAs in a positive and effective manner. Relevant life science degree / medical / nursing background, or combination of education and experience. #Remotehub review trial#
At least four years clinical monitoring experience and/or relevant clinical trial experience.May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).Liaise with Business Development and make presentations to potential clients as required.Assist with the development of project-specific training materials for team.Participate in the development of study newsletters communication as required.Site contact for protocol clarifications and subject enrolment if CRA unavailable.Conducts project co-monitoring, assessment visits and team training.May be assigned as a reviewer of essential documents (GLP) as a 2 nd line or Independent Reviewer (IR).May be assigned as LCRA to a regional or global study.Train, mentor and/or supervise junior staff.Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
Assist the Project Team with the day-to-day management of clinical studies as required. Participate in feasibility and/or site identification activities. May translate, coordinate translations or review completed translations of critical documents. Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts. Resolve site issues and determine status for IP shipment. May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing 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. Responsible for multiple projects and must work both independently and in a team environment. Prepare site visit and telephone reports. Collect and review regulatory documents as required. Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines. 
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. Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies. Track and supervise collection of ongoing study data for purpose of regular project status reporting as required. Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation. 
May be responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications. To ensure that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH). We offer a unique working environment with a global team culture, competitive salary and benefits package. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach.
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