Full-Time
Medical Monitor
US Board-Certified Gastroenterologist
Updated on 8/11/2026
PSI CRO
1,001-5,000 employees
Global CRO delivering on-time patient enrollment
No salary listed
No H1B Sponsorship
Remote in USA
Remote
MD
 Biology & Biotech (1) |
|---|
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- A Medical Doctor degree is required.
- US Board Certification in Gastroenterology is required.
- At least 10 years of experience practicing gastroenterology is required.
- Proficiency with Microsoft Office applications is required.
- Communication, presentation, and analytical skills are required.
- Problem-solving ability and a team- and detail-oriented approach are required.
- Individuals requiring work visa sponsorship now or in the future are not eligible.
- Act as the primary point of contact for trial-specific medical and safety-related questions.
- Provide input for responses to regulatory authorities and Institutional Review Boards or Independent Ethics Committees.
- Monitor trial participant safety.
- Participate in trial participant recruitment and retention activities.
- Present medical matters at kick-off and investigator meetings.
- Train the trial team in the therapeutic area and medical aspects of the protocol.
- Develop and review trial-specific documents within the scope of medical monitoring.
- Manage ongoing trial risks related to medical monitoring.
- Perform ongoing medical review of the operational clinical trial database and support assigned Medical Reviewers.
- Review protocol deviations.
- Review RAE reports, write or review serious adverse event narratives, support the Pharmacovigilance team with outstanding safety queries, and interact with the sponsor on site safety issues.
- Review IND/SUSAR Safety Reports, update or amend essential trial records, and prepare annual IND reports with sponsor data when requested.
- Participate in the management of trial-related committees, including independent data monitoring and adjudication committees.
- Support Pharmacovigilance, Medical Data Review, and Data Management with reconciliation of safety and operational clinical trial databases.
- Review clinical study reports, including safety narratives and tables, figures, and listings.
- Provide medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable.
- Prepare for and participate in trial audits and follow up on audit findings.
- Participate in feasibility assessments of potential and ongoing trials in the country or region.
- Participate in bid defense meetings and other interactions with clients.
- Act as a medical expert and provide therapeutic expertise to other PSI departments.
- Clinical research experience is preferred.
PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Switzerland
Founded
1995
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Simplify's Take
What believers are saying
- SYNETIC cuts site identification from six weeks to minutes, speeding sponsor startup decisions.
- Mississauga office and Canada leadership expansion strengthen North American execution on pivotal phase II/III studies.
- Japan, China, and Toronto expansions deepen local access while preserving PSI’s global operating model.
What critics are saying
- SYNETIC depends on clean historical data; bad inputs poison site recommendations immediately.
- China expansion raises exposure to regulators, data localization, and cross-border trial approvals in 2026.
- PSI’s consultant-heavy CRO model faces attrition and margin pressure if recruitment quality slips.
What makes PSI CRO unique
- SYNETIC launched January 29, 2026, combining site history across 62 countries and 3 million sites.
- PSI opened Beijing April 28, 2026, positioning operations near Chinese regulators and institutions.
- PSI hired heavily in 2026, with 254 open roles and 73 posted last month.
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Benefits
Health Insurance
Paid Vacation
Flexible Work Hours
Hybrid Work Options
Remote Work Options
Wellness Program
Mental Health Support
Conference Attendance Budget
Professional Development Budget
Company News
From Shanghai to Beijing: PSI CRO expands its footprint in China with a new Beijing office. Beijing, China - April 28, 2026 - PSI CRO, a Swiss-based global full-service contract research organization, today announced the opening of its second office in China, located in China World Tower B in Beijing's Chaoyang District. In 2019, PSI established its first China office in Shanghai, where the local team has steadily grown while supporting sponsors across the region. By adding a Beijing location, PSI brings its team closer to key drug regulatory authorities and leading research institutions. China is playing an increasingly important role in global clinical development, creating a growing need for strong local operational and regulatory support. PSI's presence in Beijing helps meet that need, combining local expertise with coordinated global teams to support clear decision-making and predictable, on-time delivery for sponsors. For PSI, the Beijing office represents a targeted investment to support clients where it matters most - close to regulators, close to investigator sites, and close to strategic partners.
PSI CRO, a global clinical research organisation, has reduced clinical trial site identification from up to six weeks to minutes using SYNETIC, an AI knowledge engine powered by the Arango Contextual Data Platform. The system helps identify higher-performing trial sites and minimise costly non-enrolling institutions, which account for 30-40% of trial sites. Clinical trials can cost over $160 per minute operationally, and activating a trial site costs $30,000 or more. With 15% of sites never enrolling a single patient, failed recruitment can cost millions per study. SYNETIC unifies fragmented clinical research data into a single contextual layer, preserving relationships across investigators, institutions, protocols and historical outcomes. The platform provides explainable AI recommendations, including rationale, supporting evidence and confidence levels, enabling data-driven site selection in minutes rather than weeks.
PSI CRO strengthens Canadian presence with new Toronto office and leadership role. PSI CRO has broadened its footprint in Canada by opening a new office in the Toronto area and naming an experienced industry leader to guide its operations there. The office, located in Mississauga, Ontario, builds on the company's established Canadian presence and commitment to clinical research excellence. PSI CRO has been active in Canada for over a decade, supporting complex clinical trials with a focus on dependable delivery and strong relationships with research sites. As part of this expansion, David Allen, MBA, has been appointed as Country Manager for Canada. Allen brings more than 30 years of experience in clinical research from both sponsor and CRO environments. In his new role, he will lead efforts to enhance the company's operational capabilities in the local market and ensure alignment with PSI's global standards for on-time trial execution. PSI's continued growth in North America reflects broader trends of increasing trial activity in the region, particularly for pivotal phase II and phase III studies where precision and efficiency are critical. The expanded Toronto operations aim to further support sponsors with rigorous trial planning and execution.
TOKYO, 14 March 2025 - PSI CRO AG, a global Swiss-based clinical research organization (CRO), is pleased to announce the appointment of Sayaka Kaji as Country Manager for Japan.
Psi CRO Ag launched a CRA Academy to provide to help its team members develop therapeutic expertise as well as soft skills to manage key relationships with sites.