Clinical Research Manager (SOM Pediatric Endocrinology)

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. School of Medicine, Pediatric Endocrinology is seeking a Research Clinical Manager to working under general supervision to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, s/he should collaborate with faculty, develop SOPs, and supervise study-related activities for one or more studies. S/he has accountability for study administration and regulatory compliance. The RCM will supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites.

The Clinical Research Manager provides program management support for the research studies of Dr. Sheela N. Magge, pediatric endocrinologist and Division Director. Dr. Magge's research focuses on obesity, insulin resistance, and type 2 diabetes in children, as well as the cardiovascular complications associated with these conditions. Studies are patient-oriented, clinical studies, involving human subjects.

Specific Duties & 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.
• Other duties as assigned.

Minimum Qualifications

• 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.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Demonstrated supervisory or lead responsibilities.
• 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.

Technical Skills & Expected Level of Proficiency

• 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

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

Classified Title: Clinical Research Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($70,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F; 8:30 - 5:00
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Ped Endocrine
Personnel area: School of Medicine