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
- Prepares and submits IRB and sponsor regulatory documents
- Maintains and files documents
- Disseminates approved/current ICF and protocol documents
- 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.
Post by Marcus Creel -
As Marketing Manager, Marcus develops and implements branding and content strategy that ensures messaging accurately reflects the GuideStar brand image and engages each of the company’s target audiences.