Clinical Research Staff Orientation
A one-page orientation for clinical research coordinators and support staff, with sample role handoffs, checks for approved study documents, training routes, and query escalation guidance.
Every employee gets a seat — priced per employee in Communications & Intranet, quoted with this template ready.
Rolled out to every employee at AutoZone (125,000), PetSmart (50,000+), A.S. Watson and Raley's (20,000) — and at larger retailers we are not permitted to name.
Built for: Hospitals and academic medical centers · Clinical research organizations · Outpatient clinics and specialty care networks · Community and field-based research programs
Overview
Clinical Research Staff Orientation is a one-page reference for research coordinators and support staff who need to understand common study roles, document checks, training routes, and query escalation. Its fictional Harborview Health example uses study HV-204 to show how a support assistant, coordinator, and study support lead can resolve a document-version mismatch. The example is explicitly illustrative; each study's approved direction takes precedence.
The page includes a role-responsibility table, a before-you-use and version-disagreement checklist, descriptions of three training destinations, a worked escalation scenario, a query-routing table, and common questions. Together, these sections help a new or transferring staff member identify where to start without treating every question as a clinical decision. Clinical questions are routed to the principal investigator or trained clinician through the study-approved route.
Use this template as an orientation landing page when staff need a concise map of local responsibilities and where to ask for study-specific answers. Before publishing, replace the fictional roles and organizations with confirmed local information, identify the page owner, and verify each handoff and training route. Do not use it as a protocol, a controlled document repository, a substitute for required training, or a source of clinical instructions. It does not establish document approval, training completion, response times, or system access; those must come from the relevant study and site processes.
Standards & compliance context
- Treat the page as orientation, not as a protocol, controlled document, clinical instruction, or substitute for study-specific training.
- Require staff to confirm current approved documents through the study's controlled source and document-control process; a matching date or version on an email copy alone is not sufficient.
- Preserve the study-approved route for clinical questions and other escalations rather than inventing a site-wide process.
- Check the published page for WCAG 2.1 AA accessibility, including meaningful heading order, readable tables, descriptive image text, and keyboard-accessible navigation.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Find your way around a research study
This orientation explains the roles, document checks, training sources, and query routes research staff commonly need.
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For research coordinators and support staff in hospitals, clinics, units and field-care settings. See who usually does what on a study, how to recognise an approved study document, where study training comes from, and who to ask when something does not add up. Examples use Harborview Health, a fictional organization, and a fictional study, HV-204. The approved direction for your own study always takes precedence over this page.
Four things staff usually need
Scan the four topics to find the section that matches your immediate question.
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Plain summaries of what each topic below covers. Role responsibilities Who coordinates day-to-day study activity Who supports scheduling and records Who to hand a clinical question to Approved study documents Which document types a study uses How to check a version before you use it What to do when two versions disagree Training destinations Study-specific training from the study team Role-based research training Systems access and refreshers Queries and escalation Start with the role closest to the question Escalate when the first route cannot resolve it Keep a short written trail
Who does what on a study (sample setting)
Use these fictional role examples to see typical responsibilities and handoffs, then verify the division of work at your own site.
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Illustrative roles at Harborview Health. Titles and divisions of work differ by study and site. Role Usually handles Hands off to Research coordinator Day-to-day study activity, participant scheduling, keeping study files current Principal investigator for clinical judgement Research support staff Scheduling help, filing, preparing materials for visits Research coordinator for study questions Principal investigator Clinical oversight and decisions about the study Clinical Operations for site-level issues Study support lead Document control, training records, answering process queries Clinical Operations and Support Services
Approved study documents: what to check first
Check the study's controlled source before use, and pause when versions disagree until an authorized role confirms the current copy.
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Confirm the current approved document through your study's controlled source and document-control process. Your coordinator can direct you to that source and the authorized role for version questions. Before you use a document Find the version number and date on the document itself. Compare them with the current version listed by your study team. Use the study's controlled copy, not a saved or emailed one. When versions disagree Stop using both copies until the question is settled. Tell your research coordinator what you found and where. Let the study support lead confirm which version is current.
Where study training comes from
Distinguish study-specific instruction, role-based research training, and systems access so you can ask the right owner what applies.
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Training is assigned by role and by study; ask your coordinator or study support lead what applies to you. Study-specific training Covers the protocol and procedures for your own study. It is led by the study team, so ask them what is needed before you start work on it. Role-based research training Covers what your role needs across studies. Your manager or study support lead can tell you which sessions your role requires. Systems access and refreshers Covers the tools your study uses and any updates. Ask the study support lead how access is requested and when refreshers are scheduled.
Worked example: a document-version question on Study HV-204
Follow this fictional example to see how a version discrepancy can be reported, checked, and closed with the people handling the study.
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A fictional illustration of coordination between a coordinator and the study support lead. It is not policy. Notice the mismatch A research support assistant preparing materials for a visit sees that the printed instruction sheet says version 3, dated in March, while the study folder lists version 4. Pause and tell the coordinator The assistant sets the printed sheet aside and sends the coordinator the document title, both version numbers and where each copy was found. Coordinator checks the controlled set The coordinator compares the sheet against the study's controlled list and cannot confirm which version applies, so asks the study support lead. Support lead confirms and records The study support lead confirms version 4 is current, has the old printed copies removed, and notes the correction in the study file. Close the loop The coordinator tells the assistant which version to use and tells anyone else who handled the old copy.
Queries and escalation: where to start
Use the first contact for each question type and escalate when that route cannot resolve it.
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Start with the first route. Escalate when it cannot resolve the question. Response times are set by your study and site, not by this page. Kind of question Start with Escalate to Which document version is current Research coordinator Study support lead Training I am missing for a study Your manager or study support lead Clinical Operations and Support Services A clinical question about a participant Principal investigator or the trained clinician for the study Study-approved escalation route Scheduling or records for a visit Research support staff lead A problem that crosses studies or sites
Common questions from new research staff
Check these answers for reminders about document sources, training, query notes, and page ownership.
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Can I use a document I found in my email or on a shared drive? Use the study's approved controlled source and document-control process. A matching version number or date on an emailed or saved copy is not enough to establish that it is authorized for use. Ask the research coordinator or study support lead to confirm the approved source when you are unsure. I am not clinical. Do I still need study training? Possibly. Training follows your role and the study you support. Ask your manager or study support lead which sessions apply to you. What do I write down when I raise a query? Keep it short: what you saw, where you saw it, which study it relates to, and who you told. This helps the next person pick it up without asking you again. Who owns this page? Clinical Operations and Support Services owns this orientation. If something here does not match your study's approved direction, tell your study support lead so it can be reviewed.
How to use this template
- Replace the Harborview Health and HV-204 examples with confirmed site-specific role names, study context, and handoffs, while clearly labeling any remaining examples as illustrative.
- Confirm with the study support lead or Clinical Operations and Support Services which controlled source staff must use to verify approved study documents.
- Check each training route with the study team and manager, and state where staff should ask about study-specific, role-based, and systems training.
- Publish the page in the appropriate staff orientation area and assign a local role to receive corrections about inaccurate responsibilities or escalation routes.
- Walk new staff through the role table, document-version example, and query routes, then direct them to their study's approved instructions for work-specific decisions.
- Review the page when a handoff, training destination, controlled-document process, or approved escalation route changes, and correct outdated content.
Best practices
- Keep the fictional sample clearly identified until every role and route has been verified for the site using the page.
- Direct staff to the study's controlled source rather than treating email attachments or personal copies as authoritative.
- Preserve the pause-and-confirm response when document versions disagree; do not ask staff to choose between conflicting copies.
- Route participant-related clinical questions to the principal investigator or trained clinician through the study-approved escalation route.
- State who owns the orientation and how staff can report an inaccurate role, training route, or handoff.
- Keep query guidance observable by asking staff to record what they saw, where they found it, which study it concerns, and who they told.
- Avoid promising response times because the template states that timing is set by the study and site.
- Use short section headings and retain the role and query tables so staff can scan for an answer during a brief visit.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
Who is this orientation for, and does it apply to every study?
It is designed for research coordinators and support staff in hospitals, clinics, units, and field-care settings. Its Harborview Health roles and HV-204 example are fictional illustrations, not a universal staffing model. Follow the approved direction for your own study and site when responsibilities differ.
How often should we review this page?
The template does not prescribe a review interval. The page owner should review it when role handoffs, training routes, escalation contacts, or the controlled-document process change. Staff should report mismatches to the study support lead so the content can be checked.
Who should run the orientation for a new staff member?
The page points new staff to the research coordinator, manager, or study support lead for role- and study-specific direction. The template does not assign a formal facilitator or onboarding schedule. A site should identify the responsible role and explain how new staff receive the study's approved instructions.
Does this page replace protocol training or clinical guidance?
No. It helps staff find the usual role routes and recognize where to ask about documents and training. Study-specific training comes from the study team, and clinical questions go to the principal investigator or trained clinician through the study-approved escalation route. The approved direction for the study takes precedence.
What should staff do when two study document versions disagree?
Pause use of the conflicting copies and tell the research coordinator what the document is, which versions were found, and where they were located. The coordinator checks the study's controlled source and can ask the study support lead to confirm the current version. Do not treat an emailed or saved copy as approved just because its version number appears current.
Can we customize the roles and escalation routes?
Yes. Replace the fictional Harborview Health examples with confirmed role names and handoffs for the intended site or study. Keep clinical decisions with the authorized clinical role and preserve the study's own escalation route. Avoid presenting a local example as a rule for every site.
Does this template connect to training systems or controlled study files?
No live connections are described in the page structure. It tells staff to ask the study team or support lead about training, access, and the controlled document source. Add only confirmed destinations using your site's supported navigation and links; do not imply that this page itself grants access or records completion.
Why use a structured orientation instead of an informal explanation?
The page groups the questions new staff commonly need answered: who handles what, how to check a document, where training comes from, and where to route queries. Its tables and worked example make handoffs easier to scan than a long unstructured explanation. It still needs a named local owner and must not replace study-approved instructions.
What information should staff include when raising a query?
Record what you observed, where you found it, which study it concerns, and who you told. For a document mismatch, include the document title and both version details when available. The page does not set response times; those come from the study and site.
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Every employee gets a seat. Request pricing for Communications & Intranet and we quote into a workspace with Clinical Research Staff Orientation ready.
Rolled out to every employee at AutoZone (125,000), PetSmart (50,000+), A.S. Watson and Raley's (20,000) — and at larger retailers we are not permitted to name.
