Inside Site 204

What this team does

Runs the study where the patients are: the hospital, the clinic, the research center.

Books visits, takes consent, collects samples and writes everything down in the source.

Answers to the investigator, the sponsor's monitor and the ethics committee, often on the same day.

A day here

1. 7:30Check today's visits. Two screenings, one week 12 visit, one patient who always runs late.
2. 9:00Consent for a new patient. She has questions about the biopsy. You take the time.
3. 11:30The lab kit for the week 12 visit expired last month. You find a spare and call the lab to send more.
4. 14:00Enter yesterday's data before the monitor sees it on Thursday.
5. 16:30Three queries came in. Answer two, flag one for the PI because it needs her call.

Roles, junior to senior

• Research assistant
• Clinical research coordinator
• Research pharmacist
• Regulatory coordinator
• Lead coordinator
• Site director

1. Research assistantScheduling, kits, filing and the parts of a visit that keep the day on time.Study Conduct and Operational ExecutionInvestigational Product
2. Clinical research coordinatorThe study at the site, day to day: visits, consent, source and data entry.Clinical Research CoordinatorParticipant RightsStudy Conduct and Operational ExecutionSource Documentation and Data Integrity
3. Research pharmacistStudy drug: receiving, storing, dispensing and counting what comes back.Investigational ProductSource Documentation and Data Integrity
4. Regulatory coordinatorThe site file, ethics submissions and keeping every approval current.Regulatory AffairsRegulatory and Essential RecordsParticipant Rights
5. Lead coordinatorSeveral studies at once, training new coordinators and the hard calls with sponsors.Clinical Research CoordinatorStudy Conduct and Operational ExecutionQualityCommunication
6. Site directorWhich studies the site takes on, budgets, staffing and the relationship with sponsors.QualityCommunicationRegulatory and Essential Records

Who they talk to every day

• The Clinic
• Terminal C
• Central Lab
• Data Works
• Reg House
• City Hall

Words you will hear

Source

The first place something was written down, like the clinic note or the lab printout.

Screen fail

A patient who tried to join the study but did not meet the rules to take part.

Visit window

The days a visit is allowed to happen. Outside them it counts as a mistake.

Delegation log

The sheet that says who at the site may do which study tasks.

Query

A question from the data team about a number or entry that looks wrong.

ISF

The investigator site file. The binder, or folder, with every study document the site must keep.

Deviation

Anything done differently from the protocol. It gets written down and explained.

Common moves in and out

People arrive from nursing, medical assisting, lab work and science degrees.

Coordinators often become CRAs, the most common move in the city.

Others go into regulatory at a sponsor, site management or data management.