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Clinical Research Coordinator Lead

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 coordinate and manage work plans with over 20 collaborating clinical sites nationwide to support the clinical trial research objectives of the BIOS Clinical Trials Coordinating Centers (CTCC). Responsibilities encompass training and supervising clinical and data entry staff at various centers, ensuring adherence to specified trial cycle metrics, maintaining protocol integrity, and overseeing compliance with local, institutional, and federal regulatory requirements across the collaborative network. The Site Manager will be responsible for directing and coordinating the efforts of teams in other 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 subject recruitment, ensuring that monthly enrollment targets are achieved across all clinical sites.
Support site feasibility assessments, outlining the availability of essential local resources critical for successful trial activation and enrollment performance.
Assist sites with central IRB onboarding, ensuring timely and accurate submissions to IRBs, sponsors, and master agreements, as well as local IRB/ethics committee reviews and approvals, while collecting all necessary regulatory documents prior to site activation for subject enrollment.
Monitor site compliance with investigational products, safety event reporting, and contracting.
During trial execution, oversee site performance, assist with subject eligibility and randomization, identify local recruitment challenges, and collaborate with site teams to implement effective solutions to meet recruitment goals.
Conduct regular teleconferences and manage monthly training sessions with clinical teams, providing mentorship to new coordinators and investigators.
Ensure enrollments remain on schedule and clinical teams adhere to established performance expectations.
Support quality assurance monitors in all aspects of communication and management with enrolling center clinical teams.
Manage relationships with site investigators and execute site start-up and performance plans, assigning tasks and deadlines to site clinical teams, directing daily clinical site operations, identifying resource needs, performing quality reviews, and escalating functional, quality, and timeline issues as necessary.
Implement lean management processes to ensure sites deliver on time and within budget, maintain high-quality standards, and facilitate the smooth execution of trial policies and objectives from site launch through study activation and trial completion.
Conduct self-audits and evaluate clinical site performance; recommend modifications to protocol operations based on audit findings and revised objectives.
Track proposals and documentation through signature and approval processes, collaborating with contracts personnel and IRB Navigators.
Utilize professional judgment in managing sensitive information and organizational concerns; leverage data, statistical analysis, and predictive modeling to inform decision-making; assist investigators in deriving 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 auditing and monitoring study sites.
Cultivate and sustain strong, trusting relationships.
Stay informed about evolving clinical research technologies 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 execution. Strong negotiation, facilitation, consensus-building, and diplomacy skills, with a focus on service orientation. Demonstrated ability to operate independently while adhering to strict timelines. Capacity to make independent judgments and act on decisions regularly. Ability to manage multiple tasks simultaneously and meet various concurrent deadlines. Excellent organizational skills, analytical and problem-solving capabilities, and attention to detail. Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams. Familiarity with SharePoint and collaborative document co-authoring. Ability to learn new software applications, including electronic data capture software and project management tools, which will be provided during training. 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 vice versa, as permitted by the JHU equivalency formula. Preferred Qualifications
Experience in project/system process lifecycle, including at least 2 years of direct project management. Knowledge of formal project management methodologies. Experience in communicating trial policies and scientific concepts to investigative teams and subject-matter experts. Familiarity with research protection, federal and regulatory issues, research ethics, and project management at the task level. Experience in a higher education environment. Advanced knowledge of GCP/ICH and local regulations.

Total Rewards
The 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, and other qualifications. Johns Hopkins offers a comprehensive rewards package that supports employees' health, life, career, and retirement.

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

Diversity and Inclusion
Johns Hopkins University values diversity, equity, and inclusion, advancing 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.