Clinical Trial Associate

  • location: Sunnyvale, CA
  • type: Contract
  • salary: $45.33 - $52.22 per hour
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job description

Clinical Trial Associate

Clinical Project Associate

Job Summary

Under direct supervision, the CPA I position begins gaining experience in clinical trial

management procedures by assisting in the planning, designing, and implementation of

the client's clinical trial protocols. Will interface with internal and external stakeholders, eg, study coordinators and investigators working with confidential patient and company data. In collaboration with senior level staff, participates in data quality reviews and develops a basic understanding of the disease, molecule, and indication specific to the clinical trial assigned. Maintains a high level of professionalism with all interactions, both internal and with external stakeholders

Job Responsibilities

  • Demonstrates knowledge of site management / monitoring practices - site evaluation, patient recruitment, site initiation, monitoring, investigator meetings, drug supply management, sample management and close out
  • Participates in the review of CRF guidelines and develops understanding of ongoing clinical data review
  • Develops basic skills in performing manual in-house review of CRF data for
  • completeness and accuracy, resolving data management and data query issues with study sites and vendors
  • Participates in and develops basic knowledge of the processes used to evaluate and select potential investigators and sites
  • Interacts with sites and vendors through written and verbal communications and maintains effective management of study issues
  • Develops basic knowledge in the review process of site's informed consents against the consent template for presence of GCP requirements and protocol specific information
  • May assist in the review of informed consents for accuracy
  • Proficiency in coordination and review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
  • Supports CTM in tracking IND Safety Reports for assigned sites
  • May initiate investigational product shipments and ensures that supplies are adequate for assigned studies and sites
  • Develops basic knowledge of the investigator contract, budget, and payment process
  • May prepare site payment tracking for management review
  • Ensures that important information is consistently shared/communicated with managers, peers, team members, and vendors in a timely manner to enable effective decision-making
  • Appropriately represents functional area and clinical trial management role
  • Demonstrates willingness to go above and beyond in order to support corporate or departmental needs or goals
  • Able to facilitate functional team meetings, including preparation, agenda setting, and keeping participation on track
  • Ensures required corporate training on standard operating procedures, policies, and work instructions are completed by the due date
  • Contributes expertise to functional and cross-functional process improvement activities, as needed
  • Performs other work-related duties as assigned
Education & Qualifications

  • BA/BS or equivalent degree in a scientific discipline, RN, or healthcare related field is
  • preferred but is not required.
  • 2+ years of CRA experience in an industry setting, or two years of pharmaceutical/health care field experience
  • 1+ year of year of site monitoring experience preferred
  • Demonstrated understanding of medical terminology or clinical activities.
  • Strong verbal and written communication skills, attention to detail, and strong organizational skills are necessary
  • Demonstrates an understanding of what assigned tasks are on the critical path and uses this knowledge to guide time management and prioritization of activities
  • Understands GCP principals, their importance, and how they apply to operational activities being managed or performed as well as understands local or country-specific regulations and how they affect current study work
  • Working knowledge of TMF/CTMS maintenance and management of essential documents
  • Models integrity, fairness, and collaborative behavior in all interactions with individuals, teams and functional areas
  • Proactive about engaging the right stakeholders and leading joint efforts to achieve project objectives or corporate goals
  • Ability to multi-task under limited direction and on own initiative
  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools
  • SharePoint and filing systems experience is desirable
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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