We are seeking a Sr Clinical Research Program Manager to work under the Director of the Upper Aerodigestive Cancer Program (UAD) and the Director of Clinical Research Administration. Will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the UAD Program, both on the East Baltimore and Bayview campuses. The candidate will be responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff and ensuring research staff are properly trained. Will have a dual reporting relationship to the Director UAD Program and Director of Clinical Research Administration. Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Must understand 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.

Specific Duties & Responsibilities

Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the Program.

• Responsible for recruiting and supervising research staff in the Program, and working closely with senior staff for data management and/or regulatory personnel recruitment. Work closely with the Research Nurse Manager to recruit research nursing personnel.
• Actively assess workload and assignments among all research staff in the Program.
• Facilitate effective teamwork among research nursing, data management, and regulatory personnel.
• Responsible for development and implementation of policy and procedures for clinical research within the Program.
• Develop and conduct continuing education training for all research staff.
• Facilitate collaboration between Oncology, Radiation Oncology, and other pertinent departments to enable multidisciplinary clinical research operations.
• Facilitate collaboration between Hospital and University personnel including data management, inpatient, outpatient and research nursing, house staff and faculty.

Responsible for resource utilization and prioritization within the Program.

• Direct meetings to discuss the current and upcoming clinical trials portfolio and active research issues and staffing needs.
• Meet regularly with Program leadership to discuss availability of resources and prioritization of protocols.
• Meet regularly with Oncology Financial Administration to review clinical trial billing and staff effort distribution.
• Supervise space allocation within the designated work area.

Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.

• Assist PIs with research protocol evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc.
• Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies, as needed.
• Work with research coordinators, inpatient/outpatient nurses, research nurses, research pharmacy, and other clinical departments to optimize the practical implementation of each protocol.
• Ensure the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
• Oversee regulatory compliance; ensure research staff maintain complete and accurate research data and charts in a real time basis and are well prepared for auditing and monitoring visits.
• Ensure SKCCC Standard Operating Procedures are in practice.
• Facilitate and maintain effective communication with research sponsors, lead organizations, and regulatory agencies.

Manage clinical research budget generation and financial management of the Program in collaboration with Oncology Financial Administration.

• Establish and oversee a process to ensure OnCore calendars, Beacon builds and Prospective Reimbursement Analyses are complete and accurate.
• Work closely with Oncology Financial Administration to build clinical trial budgets and maintain a system for tracking and reporting milestones for clinical research invoicing within the Program.
• Analyze resource utilization by individual trials and within the Program 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.
• Participate in Cancer Center-wide initiatives and working groups as needed.

Special Knowledge, Skills & Abilities

• 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.

• Master's Degree in related discipline required. 
• Eight years related experience, including significant experience conducting large research projects.
• Additional education may substitute for one year experience to the extent permitted by the JHU equivalency formula.

• PhD
• 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.
• Certification as a Clinical Research Professional.

Classified Title: Sr. Clinical Research Program Manager 
Role/Level/Range: ACRP/04/ME  
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F/8:30-5:00 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Upper Aerodigestive Cancer  
Personnel area: School of Medicine