Clinical Research Site Manager

2 weeks ago

Baltimore, United States Johns Hopkins University Full time

Job Req ID:

115399

Clinical Research Site Manager

The BIOS Clinical Trials Coordinating Center within the School of Medicine Department of Neurology is seeking a 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. Ability to work with flexibility on several trials simultaneously and to meet various concurrent deadlines. Excellent negotiation, facilitation, consensus-building, and diplomacy skills, and exhibit a strong helpline orientation.
High degree of independent action and ability to adhere to strict timelines.
Excellent leadership skills with ability to negotiate and work collaboratively.
Service-oriented with excellent verbal and written communication.
Ability to make independent judgments and to act on decisions on a daily basis Ability to work for long periods of time without direction Ability to coordinate multiple sites independently and work constructively as part of a leadership team.

Minimum Qualifications
Bachelor's Degree in related field. Five years related experience in delivering effective clinical research management solutions. 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.
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 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.

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins Universitys salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: .

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the .

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.

EEO is the Law

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