Clinical Research Manager

The Johns Hopkins University

Baltimore (MD)

On-site

USD 55,800 - 97,600

Full time

14 days+

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Job summary

An esteemed academic institution is looking for a Research Program Manager to oversee clinical trials across multiple sites. This role includes managing research protocols, collaborating with faculty, and ensuring regulatory compliance. Ideal candidates will have a Bachelor's degree and five years of clinical research experience, showcasing strong organizational and leadership skills. Compensation ranges from $55,800 to $97,600 annually, commensurate with experience. The position supports a hybrid work model.

Qualifications

Five years of related experience in clinical research in an academic setting.
Advanced knowledge of GCP/ICH and local regulations.
Certification as a Clinical Research Professional preferable.

Responsibilities

Deliver and organize work plans with 20+ clinical sites.
Manage the administrative and scientific implementation of clinical protocols.
Collaborate with faculty to develop protocols and SOPs.

Skills

Organizational skills

Analytical skills

Leadership skills

Multi-site coordination

Interpersonal skills

Written communication

Oral communication

Education

Bachelor's Degree in a related field

Master's Degree in a related field

Tools

Microsoft Office Suite

SharePoint

Job description

The Department of Neurology is seeking a Research Program Managerwho will deliver and organize work plans with 20+ clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). 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 Clinical Research Manager works under the general supervision of a Pl(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. Supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites.

Specific Duties & Responsibilities

Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the Pl.
Participate in scientific discussions with collaborators, Pl's, and funding organizations.
Collaborate with Pl to ensure operational feasibility of proposed protocol/study design.
Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the Pl.
Train and provide oversight of research data management and regulatory issues.
Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services.
Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
Ensure clinical research protocol has a completed Prospective Reimbursement Analysis {PRA) and processes/systems are in place to ensure the PRA is followed when required.
Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
Contribute to presentations and manuscripts.
Hire, supervise and manage performance of other exempt-level research staff.
Other duties as assigned.

Minimum Qualifications

Bachelor's Degree in a related field.
Five years of related experience in clinical research in an academic,
Strong organizational, analytical, and leadership skills with experience in multi-site coordination.
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.

Preferred Qualifications

Master's Degree in a related field.
Certification as a Clinical Research Professional.
Formal project management training or certification.
Advanced knowledge of GCP/ICH and local regulations.
Proficiency in Microsoft Office Suite and SharePoint; ability to learn new software (e.g., eIRB, EDC systems).

Technical Skills & Expected Level Of Proficiency