360 HCS

COORDINATOR TRAINING CHECKLIST

One program to handle all talent management needs from acquisition to development

Personal Information

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Name(Required)
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MM slash DD slash YYYY

Proficiency Scale

1 – No Experience
2 – Need Training
3 – Able to perform with supervision
4 – Able to perform independently

Research Overview

Protection of human subjects(Required)
Role of research staff(Required)
Role of monitors(Required)
GCP(Required)
SOPs(Required)

Review of Protocol

Summary(Required)
Inclusion/Exclusion(Required)
Screening(Required)
Visits/Procedures(Required)
Randomization(Required)
Adverse events(Required)
Amendments(Required)

Informed Consent

Purpose(Required)
Required elements(Required)

Procedures

Read(Required)
Initials(Required)
Signatures & dates(Required)
Documentation in chart(Required)
QA check(Required)
HIPAA(Required)

Vitals

Weight(Required)
Height(Required)
Blood pressure(Required)
Heart rate/pulse(Required)
Respiration(Required)
Temperature(Required)
Conversions(Required)

Abnormal Test Results

Labs(Required)
Other tests(Required)

Lab Preparation & Shipping

Tubes(Required)
Blood draw(Required)
Centrifuges(Required)
Safety precautions(Required)
Specimen handling(Required)
Shipping(Required)
Waste handling(Required)

EKG

Lead placement & removal(Required)
Transmittal(Required)
Identifying problems(Required)

Adverse Events

Definition(Required)
AE log(Required)

SAEs

Definition and the difference(Required)
Reporting of SAEs(Required)
Sponsor(Required)
IRB(Required)

Concomitant meds & treatments

Definition(Required)
Start date & stop date(Required)
Dosing(Required)
Logs(Required)

Study Management

Source documentation(Required)
CRF completion(Required)
Screen/Consent log(Required)
Enrollment log(Required)
Communication with physicians(Required)
Communication with other staff(Required)
Visit schedules & windows(Required)
Queries(Required)

Drug Accountability

Inventory(Required)
Dispensing logs(Required)
Documentation, labels, etc(Required)
Patient compliance(Required)
Unblinding(Required)
Drug destruction policies(Required)
IVRS(Required)

Regulatory Compliance

Initial study application to IRB(Required)
IND safety reports(Required)
IRB notification(Required)
Correspondence(Required)

Shipping

FedEx/UPS/World Courier(Required)
Mail(Required)
Certified mail – to lost to follow subjects(Required)

Computer

HQ computer Systems(Required)
Dimensions -Organizational Policies- know how and where to access these(Required)
HR Exempt, weather(Required)

Study Patient Evaluation

Screen potential patient(Required)
Screen documentation(Required)
Screening CRF(Required)
Enroll eligible participant(Required)
Randomize new patient(Required)
Dispense/dose study med(Required)
Randomization CRF(Required)
Follow-up visit(Required)
Follow-up source doc(Required)
Follow-up CRF(Required)
SAE/clinical event source(Required)
SAE sponsor worksheets(Required)
Queries(Required)

Monitor Visits

Scheduling: PI, study manager, space(Required)
Availability of charts(Required)
Availability of coordinator(Required)
Policies relating to monitors(Required)
Meeting with PI(Required)
Tiger Text(Required)

Training

Basic Life Support(Required)
Study Specific training- List below(Required)

Required Reading

Belmont report(Required)
Declaration of Helsinki(Required)
Research department SOPs(Required)
Other Training(Required)
Clinical Research Introduction(Required)
Protection of human subjects(Required)
Shipping hazardous materials /Mayo online training(Required)
HIPAA(Required)

Webinars:

Understanding Clinical Trials Protocols: Key Considerations for Effective Development and Feasibility(Required)
IRB/IEC Responsibilities and Informed Consent(Required)
Adverse Events and Safety(Required)
Investigational Product(Required)
Essential Documents(Required)
Source Documents(Required)

Authorizations

Legal Consent(Required)