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Clinical Operations Manager

3 months ago

Dayton, Ohio, United States Evolution Research Group Full time
Job Details

Job Location
LOC017 MCRC Midwest Clinical Research Center - Dayton, OH

Clinical Oper

Title: Clinical Operations Manager

Location: Dayton, OH

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. + over 5,000 completed trials, ERG continues to grow its capabilities and expand into indications where there are unmet medical needs.

Job Description:

The Clinical Operations Manager (COM) is responsible for the oversight of all aspects of Clinical Trial Team activities at a clinical trial site. The COM, in concert with the Site Director and Principal Investigator, is accountable for achieving successful delivery at the project level by meeting Sponsor contractual agreements, regulatory requirements, ERG SOPs and Work Instructions, and ERG quality standards on time and in alignment with enrollment performance expectations.

Responsibilities:
  • Proactively manage operational aspects of clinical trial delivery in coordination with clinical trial staff, such as Clinical Research Coordinators (CRC), Research Assistants (RA), Regulatory Managers, etc. Serve as the line manager for members of the Clinical Trial Team, focusing on optimizing performance and output, as well as employee engagement and career growth.
  • Coordinate with assigned CRCs and RAs, or directly lead (as assigned) the study startup process to ensure the site meets the timeline and quality expectations of all trial requirements prior to Study Initiation Visit. This would include, but is not limited to, ensuring source documentation is thorough and meets ERG and industry standards, ensuring regulatory documentation and IRB approvals in a timely manner, conducting the Trial Kick-off meeting, assigning study staff, coordinating regulatory document creation and finalization, ensure staff training prior to conducting study activities, , and engaging, contracting, managing study vendors.
  • Work proactively.
  • Accountable for ongoing updates and verification of the central site calendar, related to sponsor visits and other applicable events.
  • Review and action site visit reports; ensure tracking, follow up and resolution of site issues /action items have been completed in a timely manner.
  • Ensure timely entry of all study data into Clinical Trial Management System, managing and motivating team to expectations.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
  • Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner.
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization and site. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
Skills and Qualifications:
  • Education and experience
    • Minimum of 2 years of experience in clinical research coordination
    • Minimum of 2 years of line management or equivalent
    • College degree or licensed individual, RN, is highly preferred.
  • Requirements
    • Manage project teams through excellent interpersonal communication skills.
    • Experience motivating a group to reach a common goal and working collaboratively.
    • Planning and organizational skills should be second nature as well as being attuned and responsive to the patient's experience during the trial.
    • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
    • Excellent verbal and written communication skills