The Senior Clinical Research Program Manager will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the Hematologic Malignancies Program, both on the East Baltimore and Sibley 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. Candidate will have a dual reporting relationship to the Director/Co-Directors of Clinical Research Operations for the Division of Hematologic Malignancies and the Assistant Director of Clinical Research Administration.
DUTIES AND RESPONSIBILITIES
- Responsible for the recruitment, education, training and supervision of the research data management and regulatory personnel within the Program.
- Actively manages personnel within research data management: Assesses staff workload and determines DM assignments; Works in collaboration with Research Nurse Manager to determine individual research nursing assignments; Facilitates effective teamwork between research nursing and data management; Conducts performance appraisals for data managers and contributes to the evaluation process for Research Nursing and other staff within the research program.
- Responsible for recruiting data management and research nursing personnel, and in conjunction with the Research Nurse Manager, is responsible for hiring research nursing personnel.
- Responsible for development and implementation of policy and procedures for clinical research within the Division
- Directs a weekly meeting with Research Program Management to discuss the current and upcoming clinical trials portfolio and active research issues and staffing needs
- Meets regularly with Director/Co-Directors to discuss availability of resources and prioritization of protocols
- Supervise space allocation within the designated work area
- Facilitates collaboration between Hospital and University personnel including data management, inpatient, outpatient and research nursing, house staff and faculty.
- Assist PI with clinical protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
- Assist regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed
- Assist PI with implementation and maintenance of the research clinical protocol:
- 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 the Program
- Ensure the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
- 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.
- 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 program in collaboration with the Sr. Administrative Manager:
- 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 Sr. Administrative Manager to maintain a system for tracking and reporting milestones for financial invoicing within the Program
- Work closely with Director/Co-Directors to anticipate the impact on resources & availability of resources for clinical trials within the Division.
- Analyze resource utilization by individual trials and within programs 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. Work closely with Research Nurse Manager to ensure that Research Nurses and Data Management staff work together effectively.
Special Knowledge, Skills, or Abilities / Competencies:
- Excellent organizational skills required
- Excellent attention to detail skills required
- Knowledge of medical terminology required
- Familiar with medical procedure and laboratory fees
- Ability to manage multiple and competing priorities
- Knowledge of clinical research practices and principles required
- Ability to understand a clinical trialfinancialcontract
- Must have excellent time management skills
- Must have excellent oral and written communication skills
- Ability to work in a team and demonstrated interpersonal skills
- Must adhere 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.
Bachelor’s Degree in health-related sciences and seven (7) years’ experience in clinical research at an academic, government, or pharmaceutical industry environment required.
Must have extensive experience with clinical research sciences, regulatory affairs, experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production and prior experience managing clinical research staff required. Additional education (graduate level) may substitute for requiredexperience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Master’s Degre and certification as a Clinical Research Professional is desired.
The successful candidate(s) for this position will be subject to a pre-employment background check.