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Clinical Study Site Coordinator

2 months ago

Baltimore, Maryland, United States Johns Hopkins University Full time

Job Req ID:

Clinical Research Site Manager

The Department of Neurology is in search of a dedicated professional who will effectively manage and coordinate work plans with over 20 collaborating clinical sites nationwide to achieve the clinical trial research objectives of the BIOS Clinical Trials Coordinating Centers (CTCC). Key responsibilities include training and supervising clinical and data entry staff at various centers, ensuring adherence to specified trial cycle metrics, maintaining protocol compliance, and overseeing local, institutional, and federal regulatory requirements across the collaborative network. The Site Manager will lead and synchronize the efforts of teams in different institutions, reporting directly to the BIOS faculty and leadership.

Key Responsibilities

Initiate communication with clinical teams as they are identified and prepared for activation.
Accelerate timelines during the trial start-up phase and during participant recruitment, ensuring that monthly enrollment targets are achieved across all clinical sites.
Assist with site feasibility assessments, detailing the availability of essential local resources required for successful trial activation and participant enrollment.
Facilitate central IRB onboarding for sites, ensuring timely and accurate submissions to IRBs, sponsors, and master agreements, as well as local IRB/ethics committee reviews and approvals, while assisting in the collection of all necessary regulatory documents prior to site activation for study participant enrollment.
Monitor site compliance with investigational products, reporting safety events, and managing contracts.
During trial execution, oversee site performance, assist with participant eligibility and randomization, identify local recruitment challenges, and develop tailored remediation strategies with site teams to ensure recruitment goals are met for trial completion.
Conduct regular teleconferences and manage monthly training sessions with clinical teams, providing individual mentorship to new coordinators and investigators.
Ensure that enrollments remain on schedule and clinical teams adhere to established performance expectations.
Support quality assurance monitors in all aspects of communication and management of enrolling center clinical teams.
Manage relationships with site investigators and implement site start-up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring daily clinical site activities, identifying resource needs, conducting quality reviews, and escalating functional, quality, and timeline issues as necessary.
Apply lean management principles to ensure sites deliver on time and within budget, maintain high-quality standards, and facilitate the effective implementation of trial policies and objectives from site launch through study activation and trial completion.
Perform self-audits and evaluate the performance of clinical sites; recommend adjustments to protocol operations based on audit findings and updated goals.
Track proposals and other documentation through signature and approval processes, collaborating with contracts personnel and IRB Navigators.
Utilize professional judgment in managing sensitive information and addressing project team and organizational concerns; leverage data, statistical analysis, and predictive modeling to inform decision-making; assist investigators in deriving new insights from performance-based data.
Facilitate meetings between project stakeholders and leadership, maintain professional documentation for projects and deliverables, develop standard operating procedures as needed, and assist in the auditing and monitoring of study sites.
Cultivate and sustain strong, trusting relationships.
Stay abreast of advancements in clinical research technology and embrace innovations to modernize and enhance processes.
Act as a knowledgeable liaison between BIOS leadership and the research community.

Required Knowledge, Skills & Abilities

Proficient understanding of clinical trial designs and their application to trial execution. Strong negotiation, facilitation, consensus-building, and diplomacy skills, with a focus on service orientation. Demonstrated ability to act independently while adhering to strict timelines. Capacity to operate autonomously, with guidance from BIOS leadership. Competence in making independent judgments and decisions on a daily basis. Ability to manage multiple tasks simultaneously and meet various concurrent deadlines. Excellent organizational skills, analytical and problem-solving capabilities, and attention to detail. Ability to coordinate multiple sites independently while contributing constructively as part of a leadership team. Strong leadership skills with a collaborative approach.
Service-oriented with exceptional verbal and written communication skills.
Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
Familiarity with SharePoint and collaborative document co-authoring. Willingness to learn new software applications, including electronic data capture software and project management tools, which will be provided on the job. Minimum Qualifications
Bachelor's Degree in a related field. Five (5) years of experience in delivering effective clinical research management solutions. Additional education may substitute for required experience, and additional experience may substitute for required education, in accordance with the JHU equivalency formula. Preferred Qualifications
Experience in project/system process lifecycle, including 2+ years of direct project management. Familiarity with formal project management methodologies.
Experience in representing trial policies and communicating scientific concepts to investigative teams and subject-matter experts.
Knowledge of research protection, federal and regulatory issues, research ethics, and project management at the task level. Experience in a higher education setting.
Advanced knowledge of GCP/ICH and local regulations.
Experience with web-based data collection applications.

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. The exact salary will depend on various factors, including the successful candidate's geographic location, skills, work experience, market conditions, education/training, and other qualifications. Johns Hopkins offers a comprehensive rewards package that supports employees' health, life, career, and retirement.

Background Checks
The successful candidate(s) for this position will undergo a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practices.

Diversity and Inclusion
Johns Hopkins University values diversity, equity, and inclusion and advances these principles through its strategic framework.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.