Job description
The Department of Neurology is seeking a Clinical Research Site Managerfor the BIOS Clinical Trials Coordinating Center (BIOS CTCC). The Clinical Research Site Manager oversees sitelevel execution of large, multicenter clinical trials by leading site startup, driving enrollment performance, managing investigator relationships, and ensuring consistent protocol implementation across a national network of collaborating clinical sites. The role requires a high degree of independence, operational leadership, and performancedriven site management.
Specific Duties & Responsibilities
Oversee and coordinate the work of teams in other institutions.
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 each month 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 onboarding, 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 ensure 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.
Manage site investigator relationships and execute site start-up and performance plans, assign tasks and deadlines to site clinical teams, direct and monitor clinical site work efforts daily, identify resource needs, perform 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.
Track proposals and other documentation through signature/approval processes and through collaboration with contracts personnel and IRB Navigators.
Use professional judgment in handling information and be sensitive to the project team, individual, and all levels of organizational concerns
Use data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making
Help investigators develop new insights and understanding of performance-based data.
Serve as liaison and facilitate meetings between project stakeholders and leadership
Complete and maintain professional documentation for projects and deliverables
Develop SOPs and assist in the auditing and monitoring of study sites.
Build and maintain strong, trusting relationships.
Remain 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 leadership and the research communities.
Other duties as assigned.
In addition to the duties above
Lead site startup activities across numerous external clinical sites, including feasibility assessments, resource readiness evaluations, activation timelines, and onboarding to centralized IRB and master agreement processes.
Actively track sitelevel enrollment metrics, identify underperforming sites, and design customized remediation strategies to address recruitment barriers and keep trials on pace for completion.
Serve as the primary operational liaison for site investigators and coordinators, building trust, setting expectations, assigning deliverables, and holding sites accountable for performance, quality, and timelines.
Direct and monitor daily site activities related to subject eligibility, randomization, protocol adherence, safety reporting, and investigational product compliance, escalating risks and issues as necessary.
Oversee site performance reviews; recommend operational or protocol level improvements based on performance data and evolving trial needs.
Minimum Qualifications
Bachelor’s Degree in a related field.
Five years of related experience delivering effective clinical research management solutions.
Demonstrated ability to independently manage and coordinate multiple external clinical sites. Advanced judgment and decisionmaking in highstakes, timesensitive research environments
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
Prior clinical research experience.
Technical Skills & Expected Level of Proficiency
Analytical Skills - Intermediate
Attention to Detail - Intermediate
Clinical Study Design - Intermediate
Clinical Trials - Intermediate
Forecasting - Intermediate
Interpersonal Skills - Intermediate
Oral and Written Communications - Intermediate
Process Improvement - Intermediate
Project Management - Intermediate
Regulatory Compliance - Intermediate
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Classified Title: Clinical Research Site Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.