Source Job

• 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.

• Ensure timely review, processing, and quality of Trial Master Files (TMF) according to GCP and SOPs.
• Create and execute study TMF plans, manage document indexing, and communicate changes to project teams.
• Monitor TMF health, identify risks, and support audits and inspections for compliance.

Precision Medicine Group is a global contract research organization providing clinical trial support and precision medicine services. The company values professionalism, collaboration, and quality, with a focus on maintaining inspection-ready trial master files.

• Provide GMP quality oversight for outsourced manufacturing across cell bank, drug substance, drug product, packaging, labeling, and distribution.
• Collaborate with cross-functional teams to ensure timely batch disposition, compliant documentation, and proactive quality risk management.
• Lead quality record review, manage CDMO relationships, and support regulatory inspections and filings.

Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. As a company launched from Paragon Therapeutics, it is in early clinical and preclinical stages with a focused pipeline.

• Partner with subject matter experts to assess training needs and design effective learning solutions across translational sciences, clinical operations, and regulatory compliance.
• Coordinate new hire onboarding and maintain training documentation, records, and reporting in accordance with regulatory expectations.
• Manage learning platforms, deliver instructor-led and e-learning programs, and serve as primary intake point for training requests.

Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and advanced data sciences to improve clinical research and development. The company focuses on trials from early development through approval, with embedded experience in oncology and rare disease, and operates as part of Precision Medicine Group.

• 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.

• 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.

• 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.

• 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.

• 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.

• Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
• Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
• Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.

Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.

• 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.

• 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 batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
• Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
• Mentor and develop junior QA staff and contribute to quality system improvements.

Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.

• 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.

• Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
• Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
• Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.

Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.

• 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.

• 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.

• 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.

• 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.

• Act as primary clinical point of contact with clients and lead planning, execution, and oversight of clinical studies across Latin America.
• Develop country-level recruitment strategies, guide monitoring and quality strategies, and mentor CRAs and partners.
• Collaborate with project managers on budgets, vendor management, and ensure compliance with ICH-GCP and regulatory requirements.

Precision Medicine Group is a precision medicine company that provides clinical research and commercialization services. The company is an Equal Opportunity Employer with a focus on expanding clinical operations across Latin America.