Clinical Research Site Manager Johns Hopkins University

The BIOS Clinical Trials Coordinating Center within the School of Medicine Department of Neurology is seeking a Clinical Research Site Manager who will deliver to and organize work plans with collaborating 20+ clinical sites across the country in support of clinical trial research goals. 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. This position reports to the BIOS faculty and leadership.

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 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 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.
• 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 on a daily basis, 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 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 the BIOS leadership and the research communities.

Additional Knowledge, Skills & Abilities

• Understanding and ability to apply knowledge of clinical trial designs to trial execution.
• Knowledge of GCP/ICH and local regulations.
• Proficient with web-based data collection applications.
• Ability to prioritize own work and work of others daily and weekly.
• Strong organizational skills, analytical and problem-solving abilities, and attention to detail.

• 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 related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Project/system process lifecycle experience
• Minimum of two years 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; must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills, and exhibit a strong helpline orientation.
• Experience in an academic medicine environment.

Classified Title: Clinical Research Site Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($76,700 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30-5
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine