Research - Laboratory/Non-Laboratory, Staff/Administrative
The Clinical Research Program Specialist will be responsible for the overall management of the assigned clinical trials portfolio and clinical research activities within Neurology. The candidate will be responsible for managing research staff, developing and implementing effective data management and regulatory procedures, and ensuring research staff are properly trained. Candidate will report to the Grants & Contracts Manager.
Duties and Responsibilities
Maintain a system for tracking and reporting milestones for financial invoicing within the Program.
Oversee the protocol approval process and maintain regulatory compliance within the Departmental studies.
Work with research coordinators, inpatient/outpatient nurses, research nurses, research pharmacy, and other research cores to optimize the practical implementation of the Program.
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
Work closely with Research Nurse Manager to ensure that Research Nurses and Data Management staff work together effectively.
Ensure proper conduct of 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.
Initiate and conduct meetings and other research activities with sponsors of clinical trials as needed.
Manage the process of budget generation and financial management of the program in collaboration with the Research Nurse Manager and the Grants & Contracts Analyst(s). 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.
Actively participate in Research Program Management meetings.
Actively participate in implementing the Clinical Research Management System (CRMS) within the Program.
Analyze data associated with clinical trials, as needed by the Program.
Assist regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed.
Ensure Standard Operating Procedures are in practice.
Work closely with other Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort.
Supervise space allocation within the designated work area.
Equipment, Machine, or Tool Requirements:
General computer skills, with experience with Microsoft Office
Required: BA/BS degree in Biological/Social Sciences or other appropriate discipline required.
Minimum of 5 years’ experience in complex and detailed clinical trials/medical research required.
Minimum of two years clinical experience in clinical trial and or clinical research in a patient setting required.
Demonstrated supervisory or lead responsibilities
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.
Licensure, Certification, Registration:
Certification as a Clinical Research Professional is preferred.
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
Must have working knowledge of FDA reporting requirements
Must have excellent time management skills
Must have excellent oral and written communication 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.
Classified Title: Clinical Research Program Specialist Working Title: Clinical Research Program Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: Commensurate wtih experience Employee group: Full Time Schedule: M-F 8:30 am- 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002901-SOM Neuro Research and Fin Adminion Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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