Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions * Monitors ...
... Institutional Review Board (IRB) policy related to human use research * Must be able to pass a Tier ... Remote (Virtual) - US - US (Primary) Education Master's Degree
... Institutional Review Board (IRB) policy related to human use research * Must be able to pass a Tier ... Remote (Virtual) - US - US (Primary) Education Master's Degree
Director of Research Ethics and Integrity
Hall, NY · On-site +1
$80K/yr
... the Institutional Review Board, instruction in the responsible conduct of research, and ... Remote work is not a right, it is a work arrangement that can be modified or revoked by Miami ...
Director of Research Ethics and Integrity
Hall, NY · On-site +1
$80K/yr
... the Institutional Review Board, instruction in the responsible conduct of research, and ... Remote work is not a right, it is a work arrangement that can be modified or revoked by Miami ...
Director of Research Ethics and Integrity
Oxford, OH · On-site +1
$80K/yr
... the Institutional Review Board, instruction in the responsible conduct of research, and ... Remote work is not a right, it is a work arrangement that can be modified or revoked by Miami ...
Director of Research Ethics and Integrity
Oxford, OH · On-site +1
$80K/yr
... the Institutional Review Board, instruction in the responsible conduct of research, and ... Remote work is not a right, it is a work arrangement that can be modified or revoked by Miami ...
Research Compliance Specialist II
Chicago, IL · On-site +1
$72K - $88K/yr
... process and review Institutional Review Board (IRB) submissions and conflict of interest (COI ... This is a full time US-REMOTE role. This salaried position may require working additional hours at ...
Research Compliance Specialist II
Chicago, IL · On-site +1
$72K - $88K/yr
... process and review Institutional Review Board (IRB) submissions and conflict of interest (COI ... This is a full time US-REMOTE role. This salaried position may require working additional hours at ...
Research Compliance Specialist II
Chicago, IL · Remote
$72K - $88K/yr
... process and review Institutional Review Board (IRB) submissions and conflict of interest (COI ... This is a full time US-REMOTE role. This salaried position may require working additional hours at ...
Research Compliance Specialist II
Chicago, IL · Remote
$72K - $88K/yr
... process and review Institutional Review Board (IRB) submissions and conflict of interest (COI ... This is a full time US-REMOTE role. This salaried position may require working additional hours at ...
Senior Clinical Research Associate
Chicago, IL · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
Chicago, IL · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
Washington, DC · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
Washington, DC · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
Miami, FL · On-site +1
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
Miami, FL · On-site +1
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
New York, NY · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Senior Clinical Research Associate
New York, NY · On-site +1
$110K - $138K/yr
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...
Regulatory Analyst - Remote
Miami, FL · On-site +1
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary ...
Regulatory Analyst - Remote
Miami, FL · On-site +1
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary ...
Regulatory Analyst - Remote
Miami, FL · On-site +1
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary ...
Regulatory Analyst - Remote
Miami, FL · On-site +1
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up to study closure, including communicating with ancillary ...
Research Project Manager at Susan Hirt Hagen CORE, Penn State Behrend
Erie, PA · On-site +1
$69K - $88K/yr
Approval of remote and hybrid work is not guaranteed regardless of work location.For additional ... Ensure research activities adhere to Institutional Review Board (IRB) requirements and ethical ...
Research Project Manager at Susan Hirt Hagen CORE, Penn State Behrend
Erie, PA · On-site +1
$69K - $88K/yr
Approval of remote and hybrid work is not guaranteed regardless of work location.For additional ... Ensure research activities adhere to Institutional Review Board (IRB) requirements and ethical ...
$33K - $48K/yr
Approval of remote and hybrid work is not guaranteed regardless of work location.For additional ... institutional review board protocols, preliminary data cleaning and management, implementing ...
$33K - $48K/yr
Approval of remote and hybrid work is not guaranteed regardless of work location.For additional ... institutional review board protocols, preliminary data cleaning and management, implementing ...
Remote Institutional Review Board information
What are some common challenges faced by remote Institutional Review Board (IRB) members, and how can they be addressed?
What is a remote Institutional Review Board (IRB)?
What are the key skills and qualifications needed to thrive as a remote Institutional Review Board (IRB) member?
What is the difference between Remote Institutional Review Board vs Remote Clinical Research Coordinator?
| Aspect | Remote Institutional Review Board | Remote Clinical Research Coordinator |
|---|---|---|
| Required Credentials | IRB certification, research ethics training | Clinical research training, sometimes IRB knowledge |
| Work Environment | Review boards, ethical oversight, administrative | Participant coordination, data management, site communication |
| Employer & Industry Usage | Hospitals, research institutions, biotech firms | Pharmaceutical companies, research sites, CROs |
The Remote Institutional Review Board primarily focuses on ethical review and approval of research protocols, requiring knowledge of research ethics and IRB certifications. In contrast, the Remote Clinical Research Coordinator manages study logistics, participant interactions, and data collection. While both roles support clinical research, the IRB role emphasizes oversight and compliance, whereas the coordinator handles day-to-day study operations.

Full-time
Re-posted 6 days ago
Job description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Home-Based in United States
Responsibilities:
- Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
- Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
- Monitors trial participant safety
- Participates in trial participant recruitment boost and retention activities
- Presents on medical matters at kick-off and investigator meetings
- Trains trial team in the therapeutic area and medical aspects of the protocol
- Develops and reviews trial-specific documents within the scope of medical monitoring
- Manages ongoing trial risks related to medical monitoring
- Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
- Reviews protocol deviations
- Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
- Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
- Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
- Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
- Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)
- Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
- Prepares for and participates in trial audits, follows up on audit findings
- Participates in feasibility assessment of potential and ongoing trials in the country/region
- Participates in bid defense meetings and other interactions with clients
- Acts as a medical expert and provides therapeutic expertise to other PSI departments
- Medical Doctor degree required
- US Board Certification in Gastroenterology required
- Experience as a practicing Gastroenterology (minimum of 10Â years)
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.