Wake Research Associates - 3100 Duraleigh Road, Suite 304, Raleigh, NC 27612 image

Clinical Research Site Manager

Atlanta, Georgia, United States

Description

WR- Mount Vernon Clinical Research , LLC , site location for M3 Wake Research Inc. an integrated research site network, is seeking a Clinical Research Site Manager to oversee all aspects of the clinical trial management for their Sandy Springs, Georgia location and act as a point of contact in site management practices.

Responsibilities include:

  • Site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
  • Conducting pre-study site selection visits and assessments
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
  • Scheduling of staff to cover subjects visit needs
  • Conducting staff reviews
  • Work to assure enrollment goals of the study center are being met
  • Monitor subject visits
  • Support the team and investigators in overall conduct of the trials
  • Follow the established monitoring SOP’s both corporate and clinical as well as protocol for specific monitoring plans.
  • Work with QA/QC program prior to sponsor visit.
  • Oversee employees work before monitoring.
  • Review budgets that clinical research costs and physician’s costs are covered.
  • Work with the corporate office for evaluating recruitment plans and study start up.
  • Oversee training for all protocol training as well as required for regulations, compliance and up-to-date training.

Requirements

  • A minimum of five (5) years relevant experience as a clinical research associate or clinical research coordinator is a must.
  • Site management background is required for this position. Only qualified and experienced applicants will be considered.
    Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
  • Must have experience managing trials.
  • Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
  • Solid teamwork, organizational, interpersonal, and problem-solving skills.
  • Strong communication and written skills, attentive to detail and proficient computer skills.
  • An ability to consume, absorb, and analyze large amounts of information.
  • Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
    Strong computer skills in appropriate software and related company clinical systems is required

Benefits

  • Competitive salary
  • Comprehensive benefits package – Medical, Dental, Vision, Life , FSA and 401K
  • Paid time off