Location: Baltimore, Maryland
Internal Number: 108091-en_US
The 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.
Specific Duties & Responsibilities
- The Site Manger will have the critically important responsibility for establishing early lines of communication with the clinical teams as they are identified, selected and prepared for activation.
- Will be integral to propel accelerated timelines during the trial start-up cycle and then 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, the Site Manger will oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to 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.
- The Site Manger is critical to keeping 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.
- Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring clinical site work efforts on a daily basis, identifying resource needs, performing 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.
- Will perform self-audits and audit performance of clinical sites; and the Site Manger will recommend changes to protocol operations based on audit results and revised goals.
- Responsible for tracking proposals and other documentation through signature/approval processes then 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; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.
- Serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of study sites.
- Building and maintaining strong, trusting relationships is critical.
- The successful candidate will have 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.
- The successful candidate will be expected to stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.
- This individual will serve as a knowledgeable liaison between the BIOS leadership and the research communities.
- This position requires a high degree of independent action and adherence to strict timelines.
- The successful candidate will be expected to operate independently, with guidance provided by BIOS leadership.
- The candidate must have background and 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.
- The position requires the ability to make independent judgments and to act on decisions on a daily basis, the ability to work for long periods of time without direction, and the ability to prioritize ones own work and work of others.
- The position also requires the ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
- The candidate must possess very strong organizational skills, analytical and problem-solving abilities, and attention to detail and demonstrate the ability to coordinate multiple sites independently and work constructively as part of a leadership team.
- Most importantly, the Site Manger will oversee and coordinate the work of teams in other institutions.
- This position reports to the BIOS faculty and leadership.
Special Knowledge, Skills, & Abilities
- Understands and can apply knowledge of clinical trial designs to trial execution.
- Advanced knowledge and experience with GCP/ICH and local regulations.
- Experience in 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.
- Bachelor's Degree required in related field.
- Five (5) years' experience in delivering effective clinical research management solutions.
- Advanced degree may substitute for some experience, to the extent permitted by the JHU equivalency formula.
- Project/system process lifecycle experience, including 2+ years of direct project management.
- Excellent leadership skills with ability to negotiate and work collaboratively.
- Service-oriented with excellent verbal and written communication and organization skills.
- Knowledge of formal project management methodologies.
- Experience in a higher education environment.
Classified Title: Clinical Research Site Manager
Starting Salary Range: $54,080-$74,390-$94,710 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
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 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.
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