Occupations and Terms of Reference › Clinical trials coordinator
Universal terms of reference · POS-134 · version 1.0 · status: draft · next review 2027-10-27
Clinical trials coordinator
To coordinate clinical trials of medicines, so that trials are safe, ethical, well-recorded and compliant with good clinical practice.
Each part of this page links to the related trainings, competencies and policies. The links are the same for every facility, so an organisation can see at a glance what a role requires and what it is trained in.
Job description
Job summary. You coordinate clinical trials. You check approvals, manage trial files, handle investigational product, and make sure every participant's data and safety reports are recorded correctly.
Reports to: Chief pharmacist.
Leads or supervises: No direct reports.
What you do on a typical day
- Keep trial files complete and current.
- Check ethics and regulatory approvals before work starts.
- Manage investigational product with pharmacy.
- Record adverse events and report them on time.
- Prepare trial reports for sponsors and the ethics committee.
Working conditions and demands
- Strict regulatory rules.
- Patient safety is paramount.
- Works with sponsors and external monitors.
What good looks like
- Trial files are complete.
- Approvals are in place before work starts.
- Adverse events are reported on time.
Place in the organogram
Reporting line, from the top: see the organogram on the Occupations page. The lines above and below this role are listed in section 3.
1. Golden rules
These rules apply in every setting.
- Patients are treated with dignity, respect and privacy at every step.
- Accurate information is given to patients and families, in a language they understand.
- Confidential information is protected and used only for care, legal and agreed purposes.
- Safety comes first: errors are reported, reviewed and learned from without blame.
- Medicines, records and appointments are handled to the standard, every time.
- Anyone can raise a concern without fear of reprisal.
- Waiting and flow are managed fairly, with patients kept informed.
- Work is done to written procedures, and deviations are reported.
2. Identification
| Item | Detail |
|---|---|
| Position code | POS-134 |
| ISCO-08 | 3254 (skill level 4) |
| ESCO | to map |
| Department | Pharmacy |
| Facility types | Hospital, Ambulatory, Transport, Medevac, Fitness, Aesthetic |
3. Reporting line and working relationships
Reports to: POS-129. Supervises: .
| Works with | Nature of the relationship |
|---|---|
| Chief pharmacist | Trial pharmacy and supply. |
| Clinical trials manager | Trial plan and delivery. |
| Ethics committee secretary | Ethics approvals. |
4. Key accountabilities
| Domain | Accountability | Evidence of delivery | Checked | Linked competencies | Linked trainings | Linked policies | Standards |
|---|---|---|---|---|---|---|---|
| Trial files | Keeps trial files complete and inspection-ready. | Files audit passed | Monthly | C-01 | T-04 · T-06 | POL-DATA | 1 |
| Adverse events | Reports adverse events within the required time. | Reports on time 100% | As needed | C-02 | T-05 | POL-INC | 2 |
| Investigational product | Handles and records investigational product correctly. | Product records reconciled monthly | Monthly | C-03 | T-05 | POL-SAFEG | 2 |
5. Decision rights
| The post holder decides | Consults or escalates |
|---|---|
| Trial file layout within the protocol | Serious adverse events (trial sponsor, ethics committee and regulator) |
| Scheduling of trial visits | Protocol deviations that affect participants (clinical trials coordinator and sponsor) |
6. Qualifications and experience
| ID | Qualification | Mandatory | Validity |
|---|---|---|---|
| Q-01 | Degree in health sciences or a related field | Yes | Lifetime |
| Q-02 | Good clinical practice certificate | Yes | Lifetime |
| ID | Experience | Minimum years | Mandatory |
|---|---|---|---|
| E-01 | Clinical trials coordination experience | 2 | Yes |
7. Training requirements
Recommended common practice. Each facility adapts the list to its national law. Essential items apply in every setting; recommended items apply where resources allow.
| ID | Training | Tier | When | Validity | Linked policies | Linked competencies |
|---|---|---|---|---|---|---|
| T-01 | Facility induction | essential | at_entry | Once | POL-WHISTLE · POL-EQUAL · POL-DATA | – |
| T-02 | Safeguarding adults | essential | periodic | Every 3 year(s) | POL-SAFEG | – |
| T-03 | Safeguarding children | essential | periodic | Every 3 year(s) | POL-SAFEG | – |
| T-04 | Data protection and confidentiality | essential | annual | Every 1 year(s) | POL-DATA | C-01 |
| T-05 | Incident reporting and open disclosure | essential | periodic | Every 2 year(s) | POL-INC | C-02 · C-03 |
| T-06 | Governance, accountability and assurance | recommended | periodic | Every 3 year(s) | – | C-01 |
| T-07 | Emergency and major incident command | essential | annual | Every 1 year(s) | POL-INC | – |
| T-08 | Speaking up, inclusion and equality leadership | essential | periodic | Every 2 year(s) | POL-WHISTLE · POL-EQUAL | – |
8. Health, fitness and language
| ID | Requirement | Frequency | Tier | Minimum in low-resource settings |
|---|---|---|---|---|
| H-01 | Immunity to vaccine-preventable diseases relevant to the setting, documented at entry | At entry or as set | essential | Documented hepatitis B status at entry |
| H-02 | Tuberculosis screening at entry, then as the national rule requires | At entry or as set | essential | Symptom screening at entry and after exposure |
| H-03 | Fitness-to-work assessment at entry and after serious illness or injury | Every 12 months | recommended | Fitness check at entry |
| Language | Level | Mandatory |
|---|---|---|
| Official language of the country of practice | professional | Yes |
| English | working | Yes |
9. Competencies by level
| ID | Competency | Foundation | Practitioner | Expert | Assessed by | Revalidate | Linked trainings |
|---|---|---|---|---|---|---|---|
| C-01 | Trial file and regulatory management | Keeps files current | Manages trial files | Designs trial file systems | File audit | Every 12 months | T-04 · T-06 |
| C-02 | Adverse event reporting | Records adverse events | Reports adverse events on time | Designs reporting systems | Safety audit | Every 12 months | T-05 |
| C-03 | Investigational medicine handling | Handles product | Manages product records | Designs product controls | Product audit | Every 12 months | T-05 |
10. Performance evaluation
- Probation: 6 months, with a sign-off review (recommended value).
- Appraisal: every 12 months against the competencies and indicators below.
| ID | Indicator | Target | Data source | Frequency |
|---|---|---|---|---|
| PI-01 | Trial files audit passed | 100% | file audit | Monthly |
| PI-02 | Adverse events reported on time | 100% | safety log | As needed |
| PI-03 | Product records reconciled | 100% | product log | Monthly |
11. Career ladder and promotion
| Level | Role | Minimum experience to move on | Qualifications | Competency minimums | Trainings required | Assessment |
|---|---|---|---|---|---|---|
| Executive | Clinical trials coordinator | 2 years (recommended) | Q-01, Q-02 | C-01 practitioner, C-02 practitioner | T-04 · T-05 | Executive appointment and performance review |
12. Policies the post holder follows
Each policy is a standard template that the facility adopts and adapts. Templates are maintained centrally, so every facility works from the same version.
POL-SAFEG · Safeguarding adults and children
Purpose: Protect patients from abuse, neglect and harm, and make sure every concern is recognised and acted on.
Scope: All staff, volunteers and contractors.
Key rules:
Scope: All staff, volunteers and contractors.
Key rules:
- Recognise signs of abuse and neglect and record them factually.
- Report every concern to the designated safeguarding lead the same shift.
- Do not investigate alone.
- Share information only as the safeguarding procedure allows.
POL-DATA · Data protection and confidentiality
Purpose: Keep patient and staff information private, secure and used only for care and legal purposes.
Scope: All staff who access records or systems.
Key rules:
Scope: All staff who access records or systems.
Key rules:
- Access only the records needed for your work.
- Keep records secure; do not leave screens or paper unattended.
- Do not share information without a lawful basis.
- Report any breach to the data protection officer within 24 hours.
Linked trainings: T-10 · Review every 12 months · Template 0.1 (draft)
POL-WHISTLE · Speaking up (whistleblowing)
Purpose: Let staff raise patient safety or conduct concerns without fear of reprisal.
Scope: All staff.
Key rules:
Scope: All staff.
Key rules:
- Raise a concern with your line manager or the named speaking-up officer.
- If that route fails, escalate to the board or the national regulator.
- Retaliation against anyone who speaks up is a disciplinary offence.
- Concerns are recorded, investigated and the outcome given to the person raising them.
Linked trainings: T-01 · Review every 12 months · Template 0.1 (draft)
POL-EQUAL · Equality, diversity and inclusion
Purpose: Give every patient and colleague fair access, respectful treatment and reasonable adjustments.
Scope: All staff and patients.
Key rules:
Scope: All staff and patients.
Key rules:
- Treat every person with dignity regardless of background.
- Make reasonable adjustments, including interpreters, for language and disability.
- Report discrimination through the speaking-up route.
- Monitor access and outcomes by group.
Linked trainings: T-01 · Review every 24 months · Template 0.1 (draft)
POL-INC · Incident reporting and open disclosure
Purpose: Report and learn from incidents and near misses, and tell patients honestly when things go wrong.
Scope: All staff.
Key rules:
Scope: All staff.
Key rules:
- Report every incident and near miss the same shift.
- Give the patient and family an honest account and an apology where appropriate (open disclosure).
- Take immediate action to protect others.
- Learn: contribute to the review and follow the agreed actions.
13. Standards that name this role
14. Record history
| Date | Change | Approved by |
|---|---|---|
| 2026-10-27 | Draft record, batch 1 of the position build | Awaiting approval |