Job Details

  • Title: Clinical Trials Management Associate
  • Code: RCI-08880
  • Location: Foster City California (CA) 94404
  • Posted Date: 09/18/2020
  • Duration: 6 Months
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  Job Description

  • Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors.
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project.
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective.
  • Travel is required.
Senior CTMA Job Responsibilities:
  • Must be familiar with routine medical/scientific terminology
  • Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports
  • May contribute to SOP development
  • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
  • May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
  • May resolve routine monitoring issues
  • Must be familiar with good documentation practices and electronic trial master file system
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues
  • Ability to develop tools and processes that increase measured efficiencies of the project
  • May be asked to assist in the training of CTMAs and CPAs
  • Assists in CRO or vendor selection
  • Coordinates CROs or vendors
  • Assists in the setting and updating of study timelines
  • May participate in departmental or interdepartmental strategic initiatives under general supervision
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
  • Assures site compliance with the protocol and regulatory requirements
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
  • Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Excellent verbal, written, interpersonal and presentation skills are required
  • Working knowledge and experience with Word, PowerPoint and Excel
Minimum Expectations/Requirements:
  • At least 3+ years of experience in Clinical Operations and a degree in a relevant scientific/medical discipline (e.g., BA, BS, RN)