Sr. Clinical Research Manager (DOM Infectious Disease)

Johns Hopkins University•Baltimore, MD

49d

About The Position

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Manager works 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. Plans and directs clinical research operations which typically involves external partners and internal collaborators, and/or national and international networks. 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. The Hepatitis B HIV Cure Consortium (BICC) is seeking a motivated and skilled Sr. Clinical Research Manager to launch and oversee the new consortium as part of the BICC administrative core at Johns Hopkins. BICC aims to establish a multinational cohort of people with HIV and chronic Hepatitis B in order to apply novel technologies and advance a functional cure for Hepatitis B. The manager will work closely with the consortium leads to manage and track the progress, timelines, reporting, and fiscal expenditure of work across multiple domestic and international institutions. The position will operate independently with guidance provided from BICC leadership with the goal of building positive relationships across consortium partners while keeping all project activities on track with programmatic timelines. The position will manage all non-laboratory aspects of the project including meeting with international site investigators to ensure recruitment and follow-up of participants is proceeding as planned, managing specimen collection and shipping for the biorepository, overseeing all regulatory components for the single IRB, and creating protocols across sites to ensure uniformity of data and specimen collection.

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 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.
Familiarity with scientific writing and communication.
Experience collaborating with subaward partners.

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 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
Create and maintain tracking systems using project management software to ensure that the consortium and investigators stay on target with milestones.
Develop project plans, timelines, presentations, and checklists for program activities and coordinate across international and U.S. based investigators, regulatory, and finance staff.
Develop relationships with consortium partners at several domestic and international institutions and facilitate advancement of consortium priorities for operational partners.
Direct standing calls and project updates, including tracking of cohort recruitment targets; inform investigators of both progress and challenges.
Prepare written reports for study sponsors and regulatory bodies.
Build a tracker for development of the biorepository. Create systems for incoming biorepository use requests from collaborators. Work with investigators to create a standardized review process for use requests.
Develop standard operating procedures for data and specimen collection to ensure uniformity across consortium partners.
Oversee and provide input on knowledge management tasks led by investigators.