Classified Title: Sr. Clinical Research Program Manager
Salary Range: $59,159.00-$81,405.00
Employee Group: Full-Time
Schedule: Mon-Fri 9:00-5:00
Employee Subgroup: Exempt
Department Name: Surgery
Personnel Area: School of Medicine
The Senior Clinical Research Program Manager will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the Department of Surgery, both on the East Baltimore and Bayview campuses. The candidate will be responsible for managing research staff, developing and implementing effective data and financial management, regulatory compliance, providing education to research staff and ensuring research staff are properly trained. Candidate will have a dual reporting relationship to the SOM Administrator and the Faculty Director of Clinical Trials.
Specific Duties & Responsibilities
Actively manages clinical research personnel within the Department:
Assesses staff workload and determines clinical trial assignments.
Facilitates effective teamwork between research staff, PIs and Department Administration.
Conducts performance appraisals for clinical research personnel.
Responsible for recruiting clinical research staff.
Responsible for development and implementation of clinical research policies and procedures for the Department of Surgery.
Directs a weekly meeting with clinical research staff to discuss the current and upcoming clinical trials portfolio, active research issues and staffing needs.
Meets regularly with Departmental leadership to discuss availability of resources and prioritization of protocols.
Supervise space allocation within the designated work area.
Assist PI with clinical research protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
Assist with informed consents and protocol amendments for investigator-initiated studies, as needed.
Assist PI with implementation and maintenance of clinical research protocols.
Oversee the protocol approval process.
Maintain regulatory compliance, including oversight of IND/regulatory work within the Program.
Work with research coordinators, inpatient/outpatient nurses, research nurses, Research Nursing Manager, research pharmacy, and other research cores to optimize the practical implementation of protocols in the portfolio.
Ensure the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
Ensure research staff maintain complete, accurate and up to date research data and charts and are well prepared for auditing and monitoring visits.
Conduct site initiation visits for studies where the PI is the Coordinating Center. Maintain communication with affiliate institutions to ensure high quality data submission, timely submission of data and adherence to guidelines.
Manage the process of budget generation and financial management of the trial.
Work closely with PI and the Institution's Office of Research Billing to ensure Insurance Coverage Analyses are completed and accurate.
Participate in Prospective Reimbursement Analysis meetings as needed.
Work closely with the SOM Administrator to maintain a system for tracking and reporting milestones for financial invoicing within the Program. Coordinate invoicing with grant administration staff as needed.
Work closely with Leadership to anticipate the impact of changes in resource availability on clinical trials within the Department.
Analyze resource utilization by individual trials to ensure research needs are anticipated and met.
Work closely with other Clinical Research Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort.
Master's Degree or PhD in related discipline.
Eight years related experience including significant experience in field conducting large research projects.
Experience in clinical research at an academic, government, or pharmaceutical industry environment.
Extensive experience with clinical research sciences, regulatory affairs
Extensive experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production.
Prior experience managing clinical research staff required
Licensure, Certification, Registration
Certification as a Clinical Research Professional is preferred.
Special Knowledge, Skills, or Abilities / Competencies
Excellent organizational skills.
Excellent attention to detail skills.
Knowledge of medical terminology.
Familiar with medical procedure and laboratory fees
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles.
Ability to understand a clinical trial financial contract
Must have excellent time management skills
Must have excellent oral and written communication skills
Ability to work in a team and demonstrated interpersonal skills
Adheres to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s).
It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.