Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.
St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
Support regulatory submissions and mentor junior staff through co-monitoring visits and training.
Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.
This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Perform on-site or remote monitoring visits to ensure site adequacy for clinical studies.
Verify investigator qualifications and support regulatory submissions.
Train site staff and ensure compliance throughout the study period.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. They have a collaborative, international team with colleagues across the globe, valuing teamwork, flexibility, and work-life balance.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
Collaborate with investigators and site teams to maintain study integrity and operational excellence.
Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.
Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.
Independently conduct and document onsite and remote monitoring visits, ensuring protocol and regulatory compliance.
Serve as primary liaison between sponsor and investigative sites, managing data queries and site communications.
Mentor junior CRAs and participate in audits, inspections, and process improvement initiatives.
Alimentiv is a clinical research organization that provides clinical trial monitoring and site management services. The company fosters a dynamic, results-driven, and high-accountability environment with a focus on quality and compliance.
Drafting, negotiating, and executing clinical site and ancillary agreements in compliance with country regulations and project timelines.
Tracking site contracting progress, providing clear rationales for delays, and escalating issues with contingency plans.
Acting as a country-level subject matter expert on site contracts for internal and sponsor stakeholders.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. They have built a collaborative international team across North America, South America, Europe, Asia, and Australia, valuing teamwork, flexibility, and work-life balance.
Oversee CRO and vendor activities while directly contributing to study start-up and conduct including site initiation and monitoring visits.
Verify accuracy and completeness of clinical data, source documentation, and regulatory files ensuring compliance with GCP, GDPR, and regulations.
Identify and resolve discrepancies in study documentation and maintain Trial Master File for audit readiness.
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care through biomimetic TAVR valves. The company has a growing and inclusive team with offices in the US, Switzerland, and Australia.
Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
Manage site relationships, perform source data verification and review, and resolve data discrepancies.
Track monitoring findings, escalate risks, and maintain inspection-ready documentation.
Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.
Provide operational leadership and on-site support for multiple clinical research sites, ensuring study execution and performance.
Ensure compliance with GCP, FDA regulations, ICH guidelines, and internal quality standards through audit readiness and CAPA management.
Build trusted relationships with Principal Investigators, site staff, and sponsors to drive collaboration and operational excellence.
We are a leading community site network and home research visit solution provider with 20+ sites and over 2,000 research-experienced healthcare professionals across the U.S. We leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access and reduce study costs.
Lead the application of the Clinical Quality Management Regime across Delivery Partners, ensuring compliance with contractual quality standards.
Use quality intelligence and performance data to assess effectiveness of controls and identify emerging risks.
Provide hands-on clinical quality expertise to diagnose performance issues and support corrective actions.
Ingeus is a leading human services provider that helps people, businesses, and communities thrive through employment, skills, and health & wellbeing services. It is a trusted partner to government and industry, committed to creating positive social impact, and fosters an inclusive culture treating everyone with dignity.