Clinical Research Associate

Global Pharmatek

Piscataway, NJFull-time

Behavioral Health Market Context

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Qualifications

  • •CRA II- min 2 years of onsite/field monitoring
  • •SrCRA-min 4 years of onsite/field monitoring
  • •Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
  • •Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • •Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • •Good planning, organization and problem solving abilities
  • •Ability to work with minimal supervision
  • •Good communication and interpersonal skills
  • •Good analytical and negotiation skills
  • •Computer competency
  • •Fluent in local office language and in English, both written and verbal
  • •Works efficiently and effectively in a matrix environment
  • •In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
  • •Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
  • •Thorough knowledge of monitoring procedures
  • •Basic understanding of the clinical trial process
  • •13 more items(s)

Responsibilities

  • •The Clinical Research Associate conducts site monitoring responsibilities for Clinical trials, according to Company Standard Operating Procedures, ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring and Close-out Visits
  • •Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
  • •Responsible for all aspects of site management as prescribed in the project plans
  • •Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • •Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • •Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
  • •Monitor data for missing or implausible data
  • •Ensure the resources of the Sponsor and Company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Company travel policy
  • •Responsible for all aspects of registry management as prescribed in the project plans
  • •Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
  • •Negotiate study budgets with potential investigators and assist the Company legal department with statements of agreements as assigned
  • •Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • •Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management
  • •Assist with training, of new employees, e.g. co-monitoring
  • •Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
  • •CRA I- min of 1 year of onsite/field monitoring
  • •13 more items(s)
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