CRA II/UtrechtDeze vacature staat offline! De opdrachtgever:Farmaceut in de omgeving van Utrecht | ||
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major activities and responsibilities Site Management: Managing relationships and activities at study sites according to International Clinical Harmonization (ICH)/Good Clinical Practices (GCP's) and SOPs, potentially for more than one therapy area. Responsibilities include: • Independently performing all types of site monitoring and auditing duties (pre-study, initiation, interim and close-out). • Managing and monitoring study conduct at sites. • Performing source document verification. • Managing clinical supplies at the site level. • Creating visit/non-visit reports. • Reviewing informed consent forms and verifying the site-informed consent process. • Assisting in the management of essential regulatory documents, from site initiation through site closeout. • Reviewing the accuracy and completeness of regulatory documents at sites. • Identifying and managing protocol deviations. • Recognizing and reporting data trends and issues of non-compliance to appropriate individuals. • Participating in the development of corrective action plans for non-compliant sites. • Overseeing site-level enrollment planning and management, including tracking patient recruitment/ enrollment. • Developing an understanding of the impact of study timelines on site management. • Communicating and reinforcing study timelines at the site level. • Participating in the Serious Adverse Event (SAE) reconciliation process at sites. • Managing the query resolution process. • Participating in Investigator Meeting activities (at times) and evaluating potential Investigators. • Participating in the development of study management documents, site training materials and/or tools for site management (at times). • Updating clinical trial databases (e.g., PROSIT) and distributing, filing and archiving clinical trial documents. Site Identification & Qualification: Researching and identifying new sites and evaluating previously used sites in order to collect a realistic assessment of a site's enrollment potential. Responsibilities include: • Participating in the identification of new study centers, including gathering basic contact information and capabilities. • Participating in the site qualification/validation process: o May evaluate site qualification for general site viability. o Works with the site to develop realistic enrollment targets. • Working with Clinical Resource Organization (CRO) monitors, as appropriate. Problem Solving: • Providing solutions to increasingly complex problems. • Suggesting solutions that are appropriate, innovative and practical. Leading Self or Others, and Department: • Working under limited supervision. • Providing training and/or guidance to site personnel. • Applying and promoting best practices. • Participating in mentoring Clinical Research Assistants and/or other CRAs. • Participating in professional meetings, symposia, and conventions to maintain competencies. • Developing contacts and relationships with peers. • Engaging in discussions surrounding projects to share experiences and knowledge. • Taking initiative for personal and professional development. • Embracing change management initiatives. • Seeking to learn from others. Contactinformatie: Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl. | ||
