Site Organization, Roles and Staff Responsibilities

1. Purpose

This SOP describes how [SITE NAME] documents its organization and reporting lines, defines research roles, manages combined roles at a small site without losing needed independence, organizes work across multiple locations, and brings staff on and off the research team, including granting and removing system access.

2. Scope

This SOP applies to all employees, contractors, per diem and agency staff who perform research activities at any [SITE NAME] location. It covers site-level organization. Study-level assignment of tasks is covered by SOP-302 Delegation of Authority. Qualification and training records are covered by SOP-103 Staff Qualification, Training and Training Records.

Follow the protocol, sponsor or IRB requirement where it is stricter than this SOP.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Organization chart

• legal entity name and each location address
• Site Director, Quality Lead, each PI and Sub-I, Regulatory Coordinator, each CRC and Lead CRC, Research Pharmacist or IP Manager, Finance / Contracts Lead and Recruitment Specialist (if used)
• reporting lines
• the named backup for each critical role
• the Location Lead for each location
• each combined role and the independence controls applied (5.3)

5.2 Role descriptions

• Principal Investigator (PI): responsible for study conduct, participant safety and data reliability at the site (SOP-101 Roles and Responsibilities of the Principal Investigator)
• Sub-Investigator (Sub-I): licensed professional who performs significant trial procedures or makes important trial decisions under PI oversight, and covers for the PI
• Site Director: business and operations lead; staffing, budgets, facilities, contracts; may also be a PI
• Quality Lead: SOP system, training program, QC, internal audit, CAPA, inspection readiness
• Regulatory Coordinator: IRB submissions, ISF and essential records, 1572 and financial disclosure collection, regulatory correspondence
• Lead CRC: day-to-day coordination of an assigned study; first contact for the sponsor monitor
• Clinical Research Coordinator (CRC): screening, consent (when delegated), visits, source, EDC entry, query resolution, scheduling
• Research Pharmacist or IP Manager: IP receipt, storage, temperature monitoring, dispensing, accountability and returns
• Finance / Contracts Lead: CDAs, CTAs, budgets, invoicing, participant payments
• Recruitment Specialist: outreach, pre-screening and advertising within IRB-approved materials
• clinical support staff (for example, phlebotomists, medical assistants, nurses): perform delegated clinical procedures within their license or certification

5.3 Combined roles and independence limits

• No one performs QC or audit of their own work. When the Quality Lead also performs study work (for example, as Regulatory Coordinator or CRC), another trained person or an external reviewer QCs that work (SOP-700 Internal Quality Control and Quality Assurance Audits).
• No one is the sole approver of an SOP they wrote (SOP-100 Writing, Approving and Controlling SOPs).
• When the protocol requires unblinded staff (for example, an unblinded pharmacist or IP Manager), those staff do not perform blinded assessments, efficacy ratings or AE causality assessments for that study, and do not share treatment information with blinded staff (SOP-305 Randomization, Blinding and Emergency Unblinding). The PI assigns blinded and unblinded roles on the delegation log (SOP-305, 5.1.2).
• Protocol-required independent raters or assessors do not take on other tasks the protocol says would compromise their independence.
• An impartial witness for consent is not a member of the study team for that study (SOP-301 Informed Consent Process and Documentation).
• A person with a significant financial interest in a study's sponsor or product follows the management plan set under SOP-104 Conflict of Interest and Financial Disclosure.
• The person who approves participant payments does not also reconcile the payment records for the same study (SOP-310 Participant Payments and Reimbursement).
• When the Site Director is also the Quality Lead, a Quality Lead review, approval or CAPA closure that concerns the Site Director's own work or decisions is done by the PI or, where the PI is the same person, by the independent reviewer named in the Site decision below.

5.4 Multiple locations

• the location is listed on the 1572 (Section 3) or in the device investigator records where the sponsor requires
• the reviewing IRB has approved or been notified of the location as its policy requires
• the sponsor has approved the location
• a CLIA certificate covering any testing done at that location is current (SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements)

5.5 Onboarding

• signs the role description
• signs a confidentiality agreement covering participant information and sponsor confidential information
• provides the documents for the qualification file (SOP-103)

5.6 Role changes

5.7 Offboarding

• pending data entry and open queries
• AE and SAE follow-up and any pending safety reports
• pending investigator signatures (for departing investigators, PI review of the outstanding items in SOP-101, 5.13.5)
• scheduled participant visits and calls
• IP accountability reconciliation for any IP the person managed

5.8 Contractors, agency and per diem staff

5.9 Network roles and site roles (Model N only)

This section applies only in Model N. Model S sites skip it.

• Quality Lead: becomes the Site Quality Lead, who handles site QC, site training records, site SOP deviations and local addenda, and reports to the Network Quality Lead for network SOPs, network audits and CAPA trending. Where Appendix B assigns all quality duties centrally, the Network Quality Lead performs them and the site names a contact for quality matters.
• Regulatory Coordinator: files and maintains the site ISF and site-specific submissions; the Network Regulatory Lead prepares central IRB submissions, keeps the central eRegulatory system and handles reliance agreements where Appendix B assigns them.
• Finance / Contracts Lead: handles site invoiceables, site reconciliation and participant payments; the Network Contracts and Finance Lead handles master agreements, CTAs, budgets and coverage analysis where Appendix B assigns them.
• Privacy Officer and Security Officer (SOP-400): keep the site's HIPAA duties for the site's own records; the Network Privacy Officer and Network Security Officer handle cross-entity data flows, shared systems and multi-entity incidents (SOP-905).
• Site Director: keeps responsibility for site staffing, facilities and operations, and works with the Network Clinical Operations Lead on study allocation and shared staff.
• PI and Sub-I: keep every investigator duty for their studies at their site (SOP-101). The Network Medical Director may advise PIs and review clinical quality across sites but does not sign for, delegate for or overrule a PI on eligibility, safety, consent or IP decisions.

6. Related Forms and SOPs

• F-102-01 Site Organization Chart and Role Assignment Record
• F-102-02 Staff Onboarding and Offboarding Checklist
• F-302-01 Delegation of Authority Log
• F-401-01 Computerized System Inventory and Access Log
• F-900-02 Network Operating Model and Appendix B Adoption Record (Model N only)
• F-904-01 Shared Staff Assignment and Credentialing Log (Model N only)
• F-905-01 Cross-Entity Data Flow Register (Model N only)
• Appendix B Central and Site Responsibility Matrix (Model N only)
• SOP-100 Writing, Approving and Controlling SOPs
• SOP-101 Roles and Responsibilities of the Principal Investigator
• SOP-103 Staff Qualification, Training and Training Records
• SOP-104 Conflict of Interest and Financial Disclosure
• SOP-105 Oversight of Service Providers and Vendors
• SOP-204 Essential Documents and the Investigator Site File
• SOP-301 Informed Consent Process and Documentation
• SOP-302 Delegation of Authority
• SOP-304 Investigational Product Management
• SOP-305 Randomization, Blinding and Emergency Unblinding
• SOP-310 Participant Payments and Reimbursement
• SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
• SOP-400 Participant Privacy and HIPAA in Research
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-700 Internal Quality Control and Quality Assurance Audits
• SOP-704 Research Misconduct and Fraud Reporting
• SOP-705 Business Continuity and Emergency Preparedness
• SOP-900 Network Governance, SOP Hierarchy and Local Addenda (Model N only)
• SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation) (Model N only)
• SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
• SOP-905 Network Data, Systems, Privacy and Records Across Sites (Model N only)

7. References