$60000 - $70000
Manage and oversee all aspects associated with clinical trials including protocol development, site selection/initiation, monitoring, study closeout, data management, and reporting. Manage overall activities to ensure compliance with company SOPs, FDA regulations, ICH/GCP Guidelines, the study protocol and clinical objectives. Travels to site to supervise and monitor clinical studies as needed.
Assist with the development of the Investigational Plan/Protocol and the ICF template
Ensure successful implementation of clinical initiatives
Develop and manage clinical trial timelines and budgets
Manage study vendors; to include oversight of clinical supplies, CRO, data management groups, central IRB, central labs, and others.
Develop data collection forms (CRFs) and other study tools for implementation and tracking of study activities
Implement recruiting/advertising support initiatives for new clinical trials and investigator sites
Ensure that protocol-specific training for Investigators, Study Coordinators, and other key study personnel is conducted and documented.
Communicate with sites and resolve inquiries and problems related to clinical investigation
Manage trial enrollment to meet timelines
Assist with obtaining required legal, ethical and technical agreements with sites participating in studies
Plan, organize and participate in investigator meetings, ad hoc scientific advisory board meetings, or DSMB meetings, as required
Assist Director with regulatory submissions, such as IND safety reports and Clinical Study Reports
Provide clinical data when needed for presentations, publications, and regulatory submissions
Maintain a high level of professional expertise through familiarity with clinical literature and participation in project meetings
BSN, BSc degree or equivalent. A minimum of five years of progressively increasing clinical research experience, including field monitoring and project management
Excellent organization and time management skills required
Thorough understanding of GCPs, CFR and ICH guidelines
Effective business skills for interactive situations with peers and sites
Outstanding oral and written communication skills
Strong interpersonal skills
Attention to detail and follow-through
Knowledge of pharmaceutical clinical development
Experience in a supervisory role an asset
Comprehensive knowledge of Microsoft software (Word, Excel, PowerPoint)
Website : http://www.hcs360.com/
HCS360 was created by a team of top national recruiters in response to what we noticed as shortcomings in the industry. By combining decades of experience we've come up with HCS360 a revolutionary new approach to the recruiting industry. HCS360 believes that a combination of the best recruiters, the best technology, and the best work life balance will equal a higher level of service and delivery to our clients. This is a REVOLUTIONARY new way of recruiting. Empowering the RECRUITER empowers the CLIENT.