The Oncology Research Information Exchange Network (ORIEN) brings the nation's leading cancer centers and bio-pharmaceutical companies together in a first-of-its kind initiative to share and study "big data" within a cutting-edge informatics environment. Together, we work on projects, including clinical trials, featuring informatics-based approaches for target and biomarker discovery, trial design and enrollment and post-market analysis. The Clinical Research Specialist will coordinate clinical research project organization, implementation, and management activities; will also serve as client (academia and industries) contact at the project operational level; organize and hold meetings with stakeholders, prepare weekly status reports, interpret data, and coordinate time lines and deliverables.
Job Specific Duties:
· Coordinate project organization, implementation, and management activities; serve as client (academia and industries) contact at project operational level; function in coordination role across the ORIEN members leading to start up at the sites and assisting members & sponsors/CROs through close out activities in a coordinating center role.
· Coordinate the assigned projects/studies/trials time line and deliverables; monitor progress to achieve contracted milestones (i.e. project plan, clinical management plan, monitoring plan, training plan, communication plan)
· Prepare weekly and/or monthly (or as needed) project status reports for assigned projects
· Organize and hold meetings with stakeholders
· Occasional travel may be required for site initiation or kick-off meetings, or other study-related needs
· Monitor ongoing resource needs for the project; liaise with internal team members and external collaborators to ensure adequate resources for the planning and execution of the clinical studies/trials
· Identify and evaluate risks, interpret data on complex issues, and implement solutions in order to ensure successful completion of studies/trials; continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved
· Track and maintain computer-assisted project management program(s) and ensure timely entry of project information
Experience & Education Requirements:
· Minimum 3+ years of working experience within the cancer clinical trials space or cancer drug clinical development and with at least one (1) year of project management role. This could include specific experience in a particular functional area; demonstrated experience in liaising and coordinating cross-functional project teams.
· Bachelor's Degree in Clinical Research, Public Health, and Allied health fields such as nursing, pharmacy, or health science required; Master's in similar disciplines preferred.
The ideal candidate will demonstrate:
· Excellent organization, communication, and management skills; Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment; Good understanding of clinical cancer research/drug development including medical & therapeutic areas, phrases & medical terminology.
· Capable of managing multiple projects simultaneously; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Proficiency in computer applications including Word, Excel, PowerPoint, project management programs; Ability to understand, interpret, and explain complex research details about trials accessing the ORIEN Clinical Trials Network; Ability to work independently and as a member of the Clinical Trial Network Team