Full-Time
Lead Site Coordinator
Clinical Research
PSI CRO
1,001-5,000 employees
Global CRO delivering on-time patient enrollment
No salary listed
Southern United States, USA
Hybrid
Hybrid work includes remote work and on-site visits across different sites.
Bachelor's, Master's
 Biology & Biotech (1) |
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- A university degree in life science, pharmacy, nursing, lab analytics, or a related field is required.
- Current Good Clinical Practice certification is required.
- International Air Transport Association certification is required.
- Current Basic Cardiopulmonary Resuscitation certification is required.
- Phlebotomy certification is required unless it is included in active professional licensure as a registered nurse or licensed practical nurse.
- Active certification in clinical research by the Association of Clinical Research Professionals, Society of Clinical Research Associates, or another approved clinical research organization is required.
- The candidate must demonstrate leadership skills and the ability to manage and train a diverse team.
- The candidate must be proficient in Good Clinical Practice and institutional review board and regulatory standards.
- The candidate must be familiar with multi-therapeutic indications.
- The candidate must demonstrate proficiency in patient assessments, including triage, medication reconciliation, vital signs, electrocardiograms, and laboratory processing.
- The candidate must understand multi-therapeutic protocol design and be able to reference protocol requirements.
- The candidate must be able to interpret and efficiently implement protocols and guidelines.
- The candidate must be proficient in patient enrollment, management, and retention.
- The candidate must be proficient in Microsoft Office.
- The candidate must be proficient in most electronic data capture and electronic medical record vendor systems.
- The candidate must have a valid category B driver's license.
- Non-standard working hours may be required depending on study procedures and patient visits.
- The candidate may be required to travel for sponsor or contract research organization-initiated training.
- The candidate must use the local language fluently.
- Support assigned medical institutions in conducting clinical trials.
- Supervise assigned site-level tasks and provide backup site or study coordinator support.
- Act as the communication link among the regional manager, medical institution staff and administrators, and sponsor or contract research organization representatives.
- Act as a liaison for recruiting new site partners.
- Identify new vendors for activities that medical institutions cannot provide.
- Facilitate proposed-study evaluations and ensure feasibility responses are provided on time.
- Identify new projects aligned with medical institution interests or unmet medical needs.
- Participate in patient recruitment, identification, and evaluation for study inclusion by confirming eligibility against inclusion and exclusion criteria.
- Perform site quality checks for protocol and standard operating procedure compliance.
- Assist with developing recruitment and retention tools, source documentation, and other site tools.
- Evaluate protocols and develop recruitment strategies to improve enrollment.
- Provide training to company and site staff on clinical research best practices and study-specific processes.
- Participate in developing and deploying the site or study coordinator training program.
- Assist local research teams with standard clinical research procedures and develop site plans for incorporating clinical trials into clinical practice.
- Assist with scheduling and preparing for sponsor or contract research organization visits.
- Track patient recruitment and enrollment and support site teams in meeting enrollment targets.
- Provide staff and investigators with updates regarding study amendments.
- Ensure timely and accurate data entry into study-specific electronic data capture systems, resolve data queries, and assist with adverse-event and protocol-deviation reporting.
- Support the handling, accountability, and reconciliation of investigational products and clinical supplies.
- Support contract and budget negotiations and oversee investigator and site payments.
- Develop mechanisms to reduce company costs or increase revenue for site partners.
- Ensure that clinical-trial staff complete required study-specific and general training before participating in trials, and complete retraining after protocol changes.
- Maintain study documents in preparation for sponsor, contract research organization, or regulatory inspections.
- Perform site-readiness inspections before sponsor, contract research organization, or regulatory inspections.
- Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards.
- Participate in on-site training of additional staff through standard education programs.
- Identify site-improvement areas and help develop tools for implementation across site partners.
- Maintain licenses and certifications applicable to the role.
- Maintain familiarity with protocols conducted at assigned regional sites and serve as a resource to company and site staff.
- Perform only tasks authorized by training and applicable licensure.
- Complete introductory standard operating procedure training and customized on-the-job training during the initial two weeks under manager supervision.
- A Master's degree in life science, pharmacy, nursing, lab analytics, or a related field 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
- Toronto expansion in January 2026 deepens PSI's North American delivery capacity.
- Beijing's April 2026 launch improves access to Chinese regulators and investigator networks.
- SYNETIC reduces non-enrolling site waste, saving studies millions in recruitment costs.
What critics are saying
- IQVIA, ICON, and Parexel can copy PSI's AI site-selection advantage quickly.
- Beijing and Toronto offices raise fixed costs if sponsor demand softens in 2026.
- A major sponsor loss would crush utilization and threaten PSI's global CRO model.
What makes PSI CRO unique
- PSI CRO opened Beijing in April 2026 to stay close to Chinese regulators.
- PSI CRO operates a 58-country platform with 3,200-plus employees worldwide.
- SYNETIC cuts site identification from six weeks to minutes with explainable AI.
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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.