The Department of Neurology is seeking a Clinical Research Site Manager who will deliver to, and organize work plans with, 20+ collaborating clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). Activities include training and managing clinical and data entry personnel at numerous centers regarding specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance across the network of collaborators. The Site Manger will oversee and coordinate the work of teams in other institutions. This position reports to the BIOS faculty and leadership.

Specific Duties & Responsibilities

• Establish early lines of communication with the clinical teams as they are identified, selected and prepared for activation.

• Propel accelerated timelines during the trial start-up cycle and during subject accrual, assuring that monthly enrollment goals are met across all clinical sites.

• Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.

• Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.

• Oversee site compliance with investigational products, reporting or safety events and contracting.

• During trial implementation oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.

• Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.

• Keep enrollments on track and clinical teams on schedule with established performance expectations.

• Provide support to quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.

• Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring clinical site work efforts on a daily basis, identifying resource needs, performing quality reviews, and escalate functional, quality and timeline issues appropriately.

• Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.

• Perform self-audits and audit performance of clinical sites; recommend changes to protocol operations based on audit results and revised goals.

• Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with contracts personnel and IRB Navigators.

• Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.

• Liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of study sites.

• Build and maintain strong, trusting relationships

• Stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.

• Serve as a knowledgeable liaison between the BIOS leadership and the research communities.

Additional Knowledge, Skills & Abilities

• Understands and can apply knowledge of clinical trial designs to trial execution.

• Excellent negotiation, facilitation, consensus-building, and diplomacy skills, and a strong helpline orientation.

• Exhibit a high degree of independent action and adherence to strict timelines.

• Ability to operate independently, with guidance provided by BIOS leadership.

• Ability to make independent judgments and act on decisions on a daily basis

• Ability to work for long periods of time without direction

• Ability to prioritize one’s own work and the work of others.

• Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.

• Strong organizational skills, analytical and problem-solving abilities, and attention to detail

• Ability to coordinate multiple sites independently and work constructively as part of a leadership team.

• Excellent leadership skills with ability to negotiate and work collaboratively.

• Service-oriented with excellent verbal and written communication and organization skills.

• Ability to prioritize own work and work of others daily and weekly.

• Strong organizational skills, analytical and problem-solving abilities, and attention to detail.

• Ability to work with flexibility on several trials simultaneously and to meet various concurrent deadlines.

• Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.

• Proficient with SharePoint, collaborating and co-authoring of documents.

• Ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.

Minimum Qualifications

• Bachelor's Degree required in related field.

• Five (5) years’ experience in delivering effective clinical research management solutions.

• Additional education may substitute for required experience and additional experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Project/system process lifecycle experience, including 2+ years of direct project management.

• Knowledge of formal project management methodologies.

• Experience representing trial policies and communicating scientific concepts to investigative teams, end-users (faculty and staff), and subject-matter experts

• Experience in research protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level.

• Experience in a higher education environment.

• Experience with REDCap preferred.

• Advanced knowledge and experience with GCP/ICH and local regulations.

• Experience in web-based data collection applications.

Classified Title: Clinical Research Site Manager

Role/Level/Range: ACRP/04/MD

Starting Salary Range: $55,800 - $97,600 Annually (Commensurate with experience)

Employee group: Full Time

Schedule: M-F 8:30 am - 5:00 pm

Exempt Status: Exempt

Location: Remote

Department name: SOM Neuro BIOS

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.