CRA/CRC I Tracks

This track was designed for the CRA/CRC I with less than 2 years of clinical research experience. Individuals may be new to clinical research or to MGH with limited knowledge of clinical research conduct, good clinical practices, regulations and common terminology associated with clinical research.

Below is a list of suggested tools and courses for skill development. Click here to download a printable checklist.

   
COURSE TITLE USUALLY OFFERED FREQUENCY
CITI (via Partners Navigator website) Online N/A
Clinical Research Conduct: Training for Research Staff at MGH (via HealthStream) Online N/A
Conducting Out of Hospital Research Visits Online N/A
IATA Shipping Training for Transportation of Biological Materials and Dry Ice Online N/A
MGH DCR Clinical Research Study Staff Orientation Manual (via HealthStream) Online N/A
MGH DCR Insight eIRB Training (via HealthStream) Online N/A
Clinical Skills Training Courses:
ECG Training
Phlebotomy
Vital Signs
Jan-Dec Monthly
Clinical Research Skills Beginner Module:
I'm New - What Should I Know?
How to read a clinical research protocol
Essential Documents: What are they? What do they mean?
Informed Consent: The Speed Dating of Clinical Research
Effective Communication with your PI and Study Staff
Making Connections: Essential Patient Outreach Skills
Summer Annually
Clinical Research Skills Intermediate Module:
Study Monitoring: Preparing for a Visit
Transitioning a Study: What to Do When You Inherit a Study
Managing up! How to Work Effectively with your PI
Developing a Strategy for IRB Submission
Monitoring the Budget, Invoicing and Tracking Payments
Creating Case Report Forms to Help Study Visits Run Smoothly and per Protocol
Fall Annually
eIRB Computer Based Training Modules Jan-Dec Monthly
IRB Roundtable:
New Protocol Submissions
Consent Form Writing
Amendments and Reporting
Continuing Review
Fall Annually
Spotlight Series
i.e. Research Match; ICH E6 Revisions; Ethics in Clinical Research; Strategies for Recruiting and Retaining Study Subjects; Payments to Research Subjects: Remuneration and Reimbursement; Community Access, Recruitment and Engagement for Study Staff
Jan-Dec Monthly
QI Bootcamp:
What is the QI Program? How Can They Help Me?
Informed Consent Process
Study Documentation
Unanticipated Problems, Adverse Events and Deviation/Violations
Investigational Product Accountability and Storage (drug and device)
Starting and Maintaining a Regulatory Binder
Potpourri of Regulatory Issues (CT.gov, audit readiness, etc.)
Summer Annually

CRC II/Sr. CRC/PM Tracks

This track targets the experienced CRC with more than 2 years of experience. These individuals have a fair understanding of MGH policies and procedures, are very familiar with the conduct of clinical research, possess adequate understanding of GCP and are able to apply to current practice. 

Below is a list of suggested tools and courses for skill development. Click here to download a printable checklist.

   
COURSE TITLE USUALLY OFFERED FREQUENCY
*Coming Soon: Communicating Science Program:
The Art of a Scientific Presentation
What Makes a Good Article? Critical Appraisal of Scientific Literature
Basics of Manuscript Writing for Clinical Researchers
Writing a Scientific Abstract
Drafting a Poster
Online N/A
Applied Biostatistics Feb - March Annually
Basic Biostatistics Jan - Feb Annually
Clinical Research Skills Intermediate Module:
Study Monitoring: Preparing for a Visit
Transitioning a Study: What to Do When You Inherit a Study
Managing up! How to Work Effectively with your PI
Developing a Strategy for IRB Submission
Monitoring the Budget, Invoicing and Tracking Payments
Creating Case Report Forms to Help Study Visits Run Smoothly and per Protocol
Fall Annually
Clinical Research Skills Advanced Module:
How to Manage Multiple Studies
Checklists to Manage Projects During the Start-Up Stage
Managing PI-initiated Studies
How to Write Study-Related SOPs
Training a New Hire: What Happens in the First 2 Weeks
Personalizing Recruitment Programs
Winter Annually
Clinical Trials Billing Jan, April, July, Oct Quarterly
CT.gov May, Oct Bi-annually
DCR Spotlight Series
i.e. Budgeting for Industry Sponsored Clinical Trials, Research Match; ICH E6 Revisions; Ethics in Clinical Research; Strategies for Recruiting and Retaining Study Subjects; Payments to Research Subjects: Remuneration and Reimbursement; Community Access, Recruitment and Engagement for Study Staff
Jan-Dec Monthly
Good Clinical Practice in Research at an Academic Research Institution May-June Annually
Introduction to R Statistical Software Varies Annually
IRB Roundtable:
New Protocol Submissions
Consent Form Writing
Amendments and Reporting
Continuing Review
Fall Annually
QI Bootcamp:
What is the QI Program? How Can They Help Me?
Informed Consent Process
Study Documentation
Unanticipated Problems, Adverse Events and Deviation/Violations
Investigational Product Accountability and Storage (drug and device)
Starting and Maintaining a Regulatory Binder
Potpourri of Regulatory Issues (CT.gov, audit readiness, etc.)
Summer Bi-annually
R Users Working Group Varies Quarterly
If applicable:
Best Practices for Conducting Study-related Home Visits (online through HealthStream) Online N/A
Developing a Peer Review Program Online N/A
Introduction to the Research Patient Data Registry (RPDR) Online N/A
Applied Methods in Survey Research and Design March Annually
Community Access, Recruitment, and Engagement (CARE) Seminar March Annually
Genetic Literacy: Understanding Concepts of Modern Genetic Research Varies Annually
Introduction to Bioinformatics: Next Generation Sequencing May Annually
Introduction to Qualitative Research Design and Methodology- Research Assistant Section May Annually
A Primer on Complex Trait Genetics: Principles for the Beginning Investigator Varies Annually
RedCap courses Varies Biannually
Responsible Conduct of ‘Omics’ Research Varies Annually
RPDR Advanced Training Varies Annually
SOCRA Certification Exam (at least 2 years of clinical research experience) Nov Annually
Study Electronic Data Capture: REDCap and StudyTRAX Varies Annually
Welcome to the Genetic Code: An Overview of Basic Genetics Varies Annually

Investigators Track

The Clinical Research Investigator Track was developed for junior faculty looking to develop skills in the conduct of clinical research.

Below is a list of suggested tools and courses for skill development. Click here to download a printable checklist.

   
COURSE TITLE USUALLY OFFERED FREQUENCY
CITI Training Online N/A
**Coming soon! Communicating Science Program:
The Art of a Scientific Presentation
What Makes a Good Article? Critical Appraisal of Scientific Literature
Basics of Manuscript Writing for Clinical Researchers
Writing a Scientific Abstract
Drafting a Poster
Online N/A
**Coming soon! Constructing a Hypothesis Online N/A
IATA Shipping Training for Transportation of Biological Materials and Dry Ice Online N/A
Applied Biostatistics Feb - March Annually
Basic Biostatistics Jan - Feb Annually
Budgeting for Industry Sponsored Clinical Research Varies Annually
Clinical Research Fellows Guide to Mentoring and Resources Sept Annually
Clinical Trials Billing Jan, April, July, Oct Quarterly
CT.gov May, Oct Bi-annually
Design and Conduct of Clinical Trials Sept - Oct Annually
Good Clinical Practice in Research at an Academic Research Institution May-June Annually
Introduction to R Statistical Software Varies Annually
IRB Roundtable:
New Protocol Submissions
Consent Form Writing
Amendments and Reporting
Continuing Review
Fall Annually
QI Bootcamp:
What is the QI Program? How Can They Help Me?
Informed Consent Process
Study Documentation
Unanticipated Problems, Adverse Events and Deviation/Violations
Investigational Product Accountability and Storage (drug and device)
Starting and Maintaining a Regulatory Binder
Potpourri of Regulatory Issues (CT.gov, audit readiness, etc.)
Summer Bi-annually
If applicable:
Introduction to the Research Patient Data Registry (RPDR) Online N/A
Applied Methods in Survey Research and Design March Annually
Bedside to Bench: Recognizing and Studying Patients that Lead to New Discoveries Varies Annually
Community Access, Recruitment, and Engagement (CARE) Seminar and Workshop March Annually
Conquering the K: Applying for an NIH Career Development Award March Annually
Considering Applying for a Career Development Award? What you Should Know Dec Annually
Epigenetics Nanocourse Varies Annually
Epigenetics: An Introduction and Applications Varies Annually
Implementation of Precision Medicine: Integrating Translational Research and Care Design Varies Annually
Innovation Workshop on Device Trials March Annually
Introduction to Bioinformatics: Next Generation Sequencing May Annually
Introduction to Omics Research Varies Annually
Introduction to Qualitative Research and QR-Focused Sessions (6) Varies Bi-annually
Next Generation Sequencing: An Introduction and Clinical Applications Varies Annually
Patient Centered Outcomes Research: Tips for Applying for a PCORI Grant Winter Annually
A Primer on Complex Trait Genetics: Principles for the Beginning Investigator Varies Annually
RedCap and StudyTRAX courses Varies Biannually
Responsible Conduct of ‘Omics’ Research Varies Annually
RPDR Advanced Training Varies Annually
Series on Global Health Research Feb - March Annually
SOCRA Certification Exam (at least 2 years of clinical research experience) Nov Annually

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