Sr. Clinical Research Program Manager

Johns Hopkins University•Baltimore, MD

1d•$66,215 - $116,130•Hybrid

About The Position

The Department of Neurosurgery is seeking a Sr. Clinical Research Manager who will work in collaboration with PI(s) to set the direction for research and is responsible for the overall management of a clinical trials portfolio and clinical research activities. This person plans and directs clinical research operations which typically involves external partners and internal collaborators, and/or national and international networks. The Sr. Clinical Research Manager 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.

Requirements

Bachelor's Degree in a related field.
Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
Demonstrated supervisory or lead experience.
Additional education may substitute for required experience and additional related experience may substitute for required education permitted by the JHU equivalency formula beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Nice To Haves

Master's Degree in a related field.
Certification as a Clinical Research Professional.

Responsibilities

Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research.
Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to decisions impacting conduct of research.
Responsible for the recruitment, education, training, and supervision of the clinical research coordinators and regulatory personnel within the program.
Responsible for development and implementation of policy and procedures for clinical research within the program.
Facilitate effective teamwork among all involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc.
Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.
Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety, etc.
Oversee preparation and submissions to IRB and act as a liaison for regulatory issues on behalf of the PI.
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
Manage clinical research budget generation and financial management of the program.
Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc.
Analyze resource utilization by individual trials to ensure research needs are anticipated and met.
Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data.
Ensure research staff maintain complete and accurate research data and charts and are well prepared for auditing and monitoring visits.
Lead study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
Contribute to manuscripts and presentations.
Other duties as assigned.