Clinical Research Manager (SOM Pediatric Endocrinology)

About the role

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The School of Medicine, Pediatric Endocrinology is seeking a Research Clinical Manager to work under general supervision to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites.

Responsibilities

• Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the PI.
• Collaborate with PI to ensure operational feasibility of proposed protocol/study design.
• Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
• Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
• Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the PI.
• Train and provide oversight of research data management and regulatory issues.
• Serve in a critical role as liaison to facilitate communication between research staff and investigators, during implementation of study procedures across multiple research sites, including quality assurance.
• Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
• Complete and maintain professional documentation, including uploading device data to server, and/or inputting, organizing, editing, and verifying accuracy of data in databases in a timely fashion.
• Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in place to ensure the PRA is followed when 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.
• Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
• Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals.
• Contribute to presentations and manuscripts.
• Hire, supervise and manage the performance of other exempt-level research staff.

Requirements

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Demonstrated supervisory or lead responsibilities.

Qualifications

• Master's degree in a related field.
• Certification as a Clinical Research Professional.
• Bilingual in English & Spanish.
• Statistics skills in STATA.
• Phlebotomy-certified preferred but not mandatory.

Skills

• Budget Management - Advanced
• Clinical 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