Job Details

  • Title: Clinical Research Associate
  • Code: RCI-83539
  • Location:
  • Posted Date: 07/27/2020
  • Duration: 12 Months
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  Job Description

Open for non-local candidates fully 100% remote if they have the right skill set

Important Updates from the manager

  • Manager is looking for a junior and a senior level CRA (remote or local) but they must have IVD exp minimum 2 years
  • For a senior level CRA manager is looking for 5 yrs. of site monitoring experience with minimum 2 yrs. of IVD experience
  • If you have a remote candidate they must have worked on previous remote projects
  • Travel is required ~25 - 30%.
  • Travel is with in United States
  • Candidate would not betravelling every week but if they are travelling they might be travelling 2 weeks in a row may be 3 and then may be no travel for 3 months
  • Manager is not looking for Clinical trail manager kind of experience
  • Looking for CRA experience
  • Bachelor’s degree preferred but if there is someone with lot of monitoring and IVD exp then manager can consider
  • Pharma and IVD are very different
  • Manager is looking for IVD experience Specifically
  • Looking for people with transferable skills
  • If you are able to fins a local candidate then candidate would need to come onsite once covid is resolved
CRA
  • Member of the clinical team responsible for conducting clinical studies according to Federal Regulations and ICH guidelines for new and modified in vitro diagnostic products.
  • This individual will be assigned to one or more projects and will assist with coordination of study activities including; assisting senior staff in study conduct and case report forms (CRFs), reagent and sample accountability, monitoring clinical documents, analyzing and evaluating clinical data generated during clinical studies, and assists with assembly of regulatory submission documents.
  • Responsible for assisting with basic study protocols, monitoring documents to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, reviewing study specific documents, and study summary records.
  • The individual ensures study compliance with protocol, clinical brochure, and overall clinical objectives.
  • This individual must work independently, communicate and coordinate well with others on study and projects teams.
  • Has established a high degree of competence in clinical research.
  • Has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research. 
  • IVD experience highly preferred, but not required.
  • Travel is required ~25 - 30%.

Position Accountabilities:

  • Complies with all policies, established procedures, regulations and Good Clinical Practice (GCP).
  • Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.
  • Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
  • Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
  • Identifies and qualifies clinical investigators and clinical sites.
  • Initiates payments to clinical sites.
  • Obtains and reviews all required essential documents necessary for study initiation.
  • Collaborates with Statistical Support with the collection and statistical analyses of clinical data.
  • Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines.
  • Assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.
  • Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.
  • Maintains accurate and timely sponsor/site correspondence and communication.
  • Reviews data, prepares, and presents clinical data reviews and data summaries.
  • Responds to audits and data queries.
  • Prepares and presents project progress reports to keep management and team informed.
  • Prepares the clinical sections of regulatory submissions and international registration packages.
  • Functions independently in the field and interacts with all levels of medical and scientific professionals.

Additional Requirements:

  • Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
  • Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups.
  • Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
  • Accountable for the project scope and scheduled completion date.
  • Works under the direction of the Clinical Project Manager