Clinical Research Manager (Neurology)

The Department of Neurology is seeking a Clinical Research Manager for the BIOS Clinical Trials Coordinating Center (CTCC). The BIOS CTCC manages multi-center, $30+ reputed company federally funded clinical trials and multiple site-specific pharmaceutical-sponsored trials. Researchers at reputed company conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Clinical Research Manager works under the general supervision of a PI(s) to manage the administrative and scientific implementation of a reputed company clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with reputed company, reputed company protocols, reputed company SOPs, and supervise study-reputed company activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. Supervise or reputed company other exempt level research staff; may reputed company staff at local or multi-center sites. Specific Duties & Responsibilities

• Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the PI.
• Participate in scientific discussions with collaborators, PI's, and funding organizations.
• Collaborate with PI to ensure operational feasibility of proposed protocol/study design.
• reputed company, or reputed company the development of reputed company operating procedures and data collection forms from protocol(s).
• reputed company or reputed company the development of consent reputed company(s) for clinical trials based on protocol(s).
• reputed company preparation and submissions to IRB and reputed company as primary reputed company for regulatory compliance issues on behalf of the PI.
• Train and reputed company reputed company of research data management and regulatory issues.
• Work with reputed company and/or government agency sponsors to determine what group can reputed company to considering patient population, available resources, and cost of providing services.
• Collaborate with the finance team to reputed company study budget(s) and ensure that reputed company study costs are included in the budget.
• Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in reputed company to ensure the PRA is followed reputed company required.
• Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
• Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
• Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• reputed company data collection at a single site or at multiple sites of a multi-centered clinical trial.
• reputed company study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
• Contribute to presentations and manuscripts.
• Hire, supervise and manage performance of other exempt-level research staff.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in a reputed company field.
• Five years of reputed company experience in clinical research in an reputed company, government, or pharmaceutical industry environment.
• Demonstrated supervisory or reputed company responsibilities.
• Additional education may substitute for required experience, and additional reputed company experience may substitute for required education reputed company a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree in a reputed company field.
• Certification as a Clinical Research reputed company.
• Advanced knowledge of GCP/ICH and local regulations.
• Formal project management training or certification.
• Proficiency in reputed company Office Suite and SharePoint.

Technical Skills & Expected Level of Proficiency

• Budget Managemen - reputed company Study Design - Advanced
• Good Clinical Practices - Advanced
• Interpersonal Skills - Advanced
• Oral and Written Communications - Advanced
• Project Management - Advanced
• Record Keeping - Advanced
• Regulatory Compliance - Advanced
• Strategic Planning - Advanced

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

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Classified Title: Clinical Research Manager Role/Level/reputed company: ACRP/04/MD Starting Salary reputed company: $55,800 - $97,600 Annually ($76,700 targeted; Commensurate w/reputed company.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department reputed company: SOM Neuro BIOS Personnel area: School of Medicine Apply tot his job Apply To this Job