Clinical Research Manager
Updated on 5/24/2023
Locations
Paducah, KY, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Requirements
  • 5+ years of clinical research coordinator experience
  • Extensive knowledge of clinical research studies, protocols, etc
  • Self starter with the ability to run with things
  • BS/BA in Life Sciences or related discipline
  • Previous GCP training and certification
  • Demonstrated ability to build strong teams and relationships
  • Strong verbal and written communication skills
  • Exceptional interpersonal skills, the ability to work independently
  • Demonstrated proficiency with word processing, spreadsheet, database, and presentation software
  • Ability to travel for clinical activities, attend investigator meetings or vendor visits/audits, as required
  • Strong organizational/prioritization skills for the management of multiple concurrent projects
  • Preferred: Nursing experience in a clinical setting
  • Thinks beyond their immediate team and contributes to making Aledade holistically better (active engagement in D&I efforts, culture initiatives, facilitating training, leading roundtables, etc.)
Responsibilities
  • Serve as the primary contact for clinical trials across the ACO to ensure appropriate communications, trial management, and meeting of timelines
  • Develop strong working relationships and maintain effective communication with study team members and key stakeholders
  • Working closely with partners on all areas of clinical trials including start-up, vendor management, subject recruitment, protocol training, data entry, and reporting in compliance with sponsor requirements
  • Manage multiple concurrent trials
  • Complete all protocol related training
  • Perform patient/research participant scheduling
  • Collect patient/research participant history
  • Collect and maintains source documentation
  • Perform data entry and query resolution
  • Support the collection and review of required essential study documents and reports
  • Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.)
  • Adhere to an IRB approved protocol
  • Collect and provide all documents required for research-related regulatory purposes
  • Coordinate and conduct the informed consent process
  • Support the safety of research subjects, report adverse events
  • Maintain all trial-related training records as required
  • Ensure all research-required equipment is appropriately calibrated
  • Coordinate protocol related research procedures, study visits, and follow-up
  • Assist with the screening, recruiting and enrollment of research subjects
  • Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities
  • Collect, process and ship laboratory specimens
  • Communicate with internal teams, investigators, ACO board, and stakeholders
  • Comply with Aledade, Clinic, Sponsor, and partner policies, standard operating procedures (SOPs) and guidelines
  • Work closely with Aledade, practice leadership, and other partners to refine clinical trial approaches and identify strategies to bring clinical research as part of care to other Aledade markets
  • Other duties as assigned
Aledade

501-1,000 employees

Primary care physician platform