Clinical Research Site Manager

The Department of Neurology is seeking a Clinical Research Site Manager who will deliver to, and organize work plans with, 20+ collaborating clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). 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. The Site Manger will oversee and coordinate the work of teams in other institutions. This position reports to the BIOS faculty and leadership.

Specific Duties & Responsibilities

• 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 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 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.
  

• 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.
  

• 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.
  

• Perform self-audits and audit performance of clinical sites; 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.
  

• 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.
  

• Build and maintain strong, trusting relationships
  

• Stay 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

• Understands and can apply knowledge of clinical trial designs to trial execution.
• Excellent negotiation, facilitation, consensus-building, and diplomacy skills, and a strong helpline orientation.