Staffing for Clinical Research: Common Positions and Key Tasks

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Jul 10, 2018

Staffing for Clinical Research: Common Positions and Key Tasks

Posted By:GuideStar Staff     /     Under: Clinical Trials Management Blog

Whether for a new program or an established entity, adequately staffing a clinical research organization can be difficult. Staffing has a significant impact on every aspect of a clinical trial, from compliance to financial viability to efficiency. Determining the correct staffing capacities and competencies for a research program takes time, dedication and an intimate knowledge of the needs of a successful clinical research organization.

One of the best ways to ensure that your current staffing structure is fully optimized is to conduct a Staff-Right Analysis. Conducting a Staff-Right Analysis allows you to evaluate every staff position and its corresponding responsibilities within your program. During this process, examine how much time is being spent on each process while also developing a full breakdown of staffing capacity to ensure your program is working at peak efficiency.

Review the following common positions and key tasks for clinical research staff so you can more efficiently conduct a Staff-Right Analysis for your site:

 Clinical Trial Program Director/Manager

  • Provides operational oversight and fiscal management for the clinical research program

 Research Finance Analyst (Pre-Award)

  • Performs and documents coverage analysis
  • Develops, negotiates and executes budget and contract language
  • Ensures congruence between budget, contract and consent forms for all studies
  • Enters study budgets into CTMS

Research Finance Analyst (Post-Award)

  • Invoices and collects sponsor fees
  • Invoices departments to collect patient stipends
  • Maintains CTMS account information relative to AR/AP

Regulatory Processing

  • Prepares and submits IRB and sponsor regulatory documents
  • Maintains and files documents
  • Disseminates approved/current ICF and protocol documents

Patient Recruiter

  • Performs schedule and record reviews for locating potential study patients
  • Triages potential patients to specialty focused coordinator

Research Nurse/Study Coordinator

  • Screens and enrolls patients to clinical trials
  • Ensures patient order sets are accurate for study compliance
  • Manages study events with patients
  • Completes quality and timely CRFs
  • Participates in SSVs, SIVs, and monitoring visits

 Data Manager/Research Assistant

  • Assists in data collection and documentation
  • Aids administrative personnel with study document preparation

Trial Procurement/Sponsor Relations

  • Locates and matches trial opportunities with PIs
  • Preserves positive sponsor relations and maintains key performance metrics to demonstrate site’s capabilities


For more information about clinical research staffing, or if you would like to discuss how GuideStar works with healthcare research sites, contact us.


GuideStar’s research team has years of experience with clinical research program site structure, staffing, finance, compliance and communications. Our services include structural and financial evaluation, budget negotiations, coverage analysis services, and more.



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