Clinical Study Associate (CSA)

Reports To (Position): Clinical Trial Manager OR DIRECTOR CLINICAL OPERATIONS 

Location: South San Francisco

Department Name: Clinical Operations 

HR Designations: Pay Status – Exempt

Objective of Position

The Clinical Study Associate (CSA) will support the study management team (SMT) in multiple areas. Acts as a central contact for clinical operations for designated project communications, correspondence and associated documentation. Performs administrative tasks to support team members with clinical trial execution as needed.

Essential Duties/ Responsibilities

  • Assists study team with clinical study(ies) administration tasks and sites for adherence to protocol, GCP and company SOPs
  • Tracks timely enrollment against plan
  • Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
  • Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking and sample tracking
  • Assists in the development of the structure of TMF and filing system and is responsible for filing and maintaining up-to-date study documents
  • Assists in the design, format and content of CRFs, study guides and subject instructions
  • Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed
  • Tracks and coordinates CRO and third-party vendor activities
  • Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference and maintains documentation as required
  • Ensures that regulatory documents are updated in a timely and appropriate manner
  • Assists with the development of site tools and clinical trial start-up activities
  • Assists with guidance from study lead, clinical trial insurance to support study start-up
  • Coordinates Acerta’s Contracts Approval Process, including obtaining appropriate approvals and signatures for all clinical agreements in accordance with corporate policies to ensure compliance and standardization of process
  • Prepares, requests and tracks Purchase Orders, invoices for contracted services across the clinical study(ies)
  • Reviews subject visit schedules, site budgets and clinical database to approve site payments
  • Confirms the accuracy of administrative data
  • Provides general support to the Clinical Operations team on other clinical trial-related duties and tasks as required
  • Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings
  • Maintains knowledge through familiarity with clinical and scientific literature and participation in professional activities
  • Ensures compliance with Acerta’s policies and procedures
  • May be required to buddy / mentor a colleague

Requirements

  • Basic knowledge of clinical trial operations, ICH and GCP Guidelines and other applicable regulatory requirements
  • Possesses excellent verbal, written, interpersonal skills
  • Possesses good organization and planning skills
  • Proficient in Microsoft Office
  • Requires the ability to sit or stand for extended periods of time

Education/ Training

  • Bachelor’s degree in a scientific discipline preferred
  • 1+ years’ experience within the Pharmaceutical / CRO industry or equivalent site experience preferred


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 

Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.