Source Job

• Own and shape a regional start-up function, building scalable systems and playbooks for site activation across Central/Eastern Europe and Georgia.
• Drive site identification, feasibility, and readiness from CDA through activation, collaborating with sites, CROs, and sponsors.
• Monitor cycle times and use data to proactively identify bottlenecks and improve activation timelines.

Iterative Health is a healthcare technology and services company that accelerates clinical research to transform patient outcomes, specializing in gastrointestinal, hepatology, obesity, and cardiology. With 250+ employees worldwide, the company fosters a collaborative, low-ego culture focused on high ownership and accountability.

• Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
• Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
• Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.

• You will monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
• You will coordinate all activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
• You will travel domestically up to 50-60% for site visits and maintain fluency in English and local language.

Precision for Medicine is a clinical research organization focused on precision medicine for oncology and rare diseases. They are a smaller CRO with a strong culture and high employee retention.

• Facilitate negotiations of site agreements and budgets to align with site activation plans.
• Customize and prepare country- and site-specific agreements, organizing translations.
• Track the status of site agreement and budget negotiation, prepare executable versions, and coordinate the signature process.

PSI is a global company founded in 1995 that brings new medicines to those who need them, working on the front line of medical science. They bring together more than 3,000 driven, dedicated, and passionate individuals who care for staff, clients, partners, and quality of work.

• Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
• Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
• Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.

Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.

• Perform in-house and remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements and study protocols.
• Support study start-up, site selection, and document tracking while assisting CRAs with on-site and remote monitoring.
• Communicate with investigative sites to resolve queries and maintain study tracking tools for deviations, SAEs, and data discrepancies.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. The environment is collaborative, international, and focused on improving patient outcomes through high-quality research.

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.

• Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
• Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
• Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.

The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.

• Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
• Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
• Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.

CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.

• Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
• Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
• Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.

Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.

• Leads writing and preparing clinical and regulatory documents for drug and device development.
• Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
• Develops knowledge of US and international regulations and participates in process improvements.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.

• Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
• Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
• Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.

AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.

• Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
• Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

• Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
• Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
• Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.

Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.

• Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
• Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
• Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.

Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.

• Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
• Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
• Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

• Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents for a top pharma partner.
• Own the end-to-end medical writing process from planning through final delivery, ensuring alignment with strategy and timelines.
• Coordinate cross-functional teams across geographies and facilitate comment resolution to drive document development.

Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.

• Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
• Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
• Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.

Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.

• Coordinate day-to-day operations across a growing network of Spravato treatment sites, including scheduling, session flow, and patient throughput.
• Manage intake logistics, insurance prior authorization tracking, and REMS-required documentation across multiple locations.
• Troubleshoot operational issues remotely in real time and support onboarding of new clinicians and partner sites.

Journey Clinical is on a mission to transform the growing mental health crisis by accelerating the adoption of frontier treatments. They have built a turnkey healthtech platform to expand access to Psychedelic-Assisted Psychotherapy, and are a fast-growing remote team.

• Partner with subject matter experts to assess training needs and design effective content across translational sciences, clinical operations, and regulatory areas.
• Coordinate new hire onboarding and serve as primary intake for training requests, ensuring alignment with functional and GCP requirements.
• Manage learning platforms, maintain training documentation, and support refinement of L&D technologies.

Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and data sciences to improve therapeutic development. The company focuses on oncology and rare disease trials across all stages, emphasizing a collaborative and innovative culture.