Clinical Research Associate

Newark, CA 94560

Posted: 03/20/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 15339

Clinical Research Associate

Newark, CA


Clinical Research Associate (CRA) reports to the  Manager – Monitoring and Study Support within  Clinical Operations and works closely with the  Clinical Program Managers (CPMs) /  Clinical Study Managers (CSMs)  to provide key support in  oversight of  study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The CRA works with clinical project team members, vendors, and CRO CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met. The CRA, in partnership with the CPM or designee, will also ensure that Clinical Operations’ leadership team  is aware of all monitoring metrics and related site critical issues. This position will reviewrelevant study documents,  trip reports,  monitoring trends, track monitoring deliverables, and recommend potential solutions to identified issues.

Essential Functions:

Major responsibilities:
  • Support clinical monitoring activities  to help ensure  the safety and well-being of study participants/patients at clinical site(s);
  • Act as primary liaison for assigned study sites to convey project information and  ensure  site(s) compliance with study protocols, plans  and guidelines, Good Clinical Practices (GCPs), and applicable regulations;
  • Oversight of the  source data verification and monitoring process and/or remote monitoring  to help ensure  data integrity.
  • Monitoring Responsibilities:
  • Oversees the conduct of  all types of clinical monitoring visits, (e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects.  Conducts these visits if needed;
  • Involved in initial review of study documents, (e.g. protocol, CRFs,  informed consent  forms,  IXRS manuals, laboratory manuals, vendor manuals [not all inclusive]);
  • Monitors site performance and compliance and provide management with necessary reports, updates and recommendations  via interaction with CRO Lead CRA / CRA(s).
  • Assists  CRO CRAs,  sites and data management with data query resolution;
  • Supports CRO and CPM or designee in training  site personnel on sponsor and regulatory requirements for study conduct; participates in  Investigator Meetings.
  • Conducts site  co-monitoring visits and follow-up to identify significant problems and issues  and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations; prepares  and/or reviews  monitoring visit reports and associated documentation;
  • Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency,  correctness  and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current, and is documented appropriately;
  • Works with the CRO CRAs to ensure  appropriate  and timely  transmission of clinical data to the data management centers;  timely  review  of  data queries, andproactive preparation for interim or final data base lock activities.  Works with the CRO CRAs and inhouse TMF representative to ensure health of the TMF during the entire course of the study;
  • Works with the CRO CRAs to ensure timely site close out visits  including identifying issues to be resolved in timely manner, assure Essential Documents, data and other study related materials are in place and completed and may be involved in preparing site close-out reports;
  • Supports and reviews site data quality trends via trip reports and data review including  queries and protocol deviations in partnership with CPM or designee;
  • Supports preparation and may develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings;
  • Develops Clinical Monitoring Plans;
  • Supports review of or develops  monitoring  tools;
  • In conjunction with Clinical Development/Operations leadership and vendor, develops and tests EDC,  IXRS, data analytics  and TMF functionality;
  • Facilitates  CRO  CRA project meetings  as necessary;
  • Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to the  CPM or designee, CRO Lead CRA andDirector of Clinical Operations.
  • Assists Clinical Operations in inspection readiness activities
  • Perform other duties as required 

Required Education and  Experience:
  • Requires a minimum of a Bachelor’ s Degree, preferably in a scientific, healthcare, or related field.
  • Requires a minimum of  three (3) years’  experience as a Clinical Trial Associate or about two (2) years of CRA experience.  Sponsor experience preferred.
  • Must have a valid driver’ s license.
  • Willingness and ability to travel  25% of the time with some overnight and weekend travel required.

Preferred  Additional Skills (i.e.,  Computer):
  • Highly organized and detail-oriented
  • Critical thinking abilities
  • Computer literate
  • Strong  problem-solving  abilities.
  • Excellent written and verbal communication and time management skills
  • Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs
  • Scientific/clinical knowledge to be able to understand the nature of the laboratory assays being studied
  • Must have excellent people skills and demonstrate the ability to work successfully in a team environment
  • Ability to prioritize and to manage multiple tasks as necessary
  • Ability to work in a team  as well as  independently, and to manage multiple priorities with minimal support in a fast pace environment
  • High customer orientation awareness and focus

Jesse Ashworth

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