Project Tasks

PROJECT TASKS
Project leader responsibilities
Collaborate with sponsors, clinicians, participating scientists and review boards
Assure project deliverables
Oversee project team
Manage activities

Statistical activities
Provide statistical and study design expertise
Analyze and interpret results
Report to sponsor and regulatory agencies
Present and publish study results

Data collection
Design Case Report Forms (paper or electronic)
Design data structures appropriate for clinical and laboratory data
Real-time reporting of adverse events
Validation of participant informed consent and eligibility
Quality assurance and study operations

Integrated program for quality assurance
Data audits
Clinical site monitoring
Protocol compliance
Regulatory compliance
Medical monitoring

Data management
Continuous access
Participant enrollment and randomization
Adverse event monitoring and triage
Clinic/site performance analysis
Data queries
Missing forms
Protocol implementation and management tools
Study reports for sites and sponsor

Medical and technical writing
Protocol documents and study manuals
Training materials
Progress reports
Regulatory submissions
Information communications
Manuscripts for publication
Abstract and publications tracking
Standard Operating Procedures

Laboratory activity oversight
Assay performance
Distribution of test agents
Quality control monitoring
Specimen tracking and inventory
Data audit

Information technology
Analyze system requirements
Identify best commercially available products
Develop and validate novel software applications
Provide system validation, feedback, tracking, and security
Provide seamless, secure access to study information
Deploy project-focused data and management system

Regulatory
IND, NDA, and BLA submissions
Protocol and amendment development and submission to FDA
Medical monitoring
Serious Adverse Event (SAE) tracking and reporting to FDA
24 - hour Adverse Event (AE) toll-free hotline
Annual reports including safety, SAE, and AE summaries

Administrative support
Schedule conference calls and meetings
Prepare and distribute paper and electronic documents
Manage conferences
Provide Internet - accessible study operations information, including operations manuals, protocols, reports, meeting minutes and other communications necessary for study center personnel

Special functions for particular projects
Store and distribute trial drugs and devices
Process specimens
Coordinate laboratory activities
Recruit special medical or technical consultants
Engage subcontractors when necessary
Identify central IRB
Process payments to sites
Ophthalmic clinical training & certification support