Source Job

• Manage TMF operations activities for multiple complex studies or sponsor portfolios.
• Oversee Trial Master File quality control including planning, tracking, and reporting.
• Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.

This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.

• Support the Quality Management System including SOPs, training, and CAPA processes.
• Coordinate and conduct internal audits, vendor audits, investigator site audits, and trial master file audits.
• Provide QA consultation and support to project teams, and manage quality issues and corrective actions.

Precision for Medicine is a Clinical Research Organisation that combines novel clinical trial designs with advanced biomarker and data analytics solutions. The company has a strong focus on rare diseases and oncology, with a global team and a culture that values employee contributions and collaboration.

• 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.

• 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.

• Support Clinical Trial Managers in the day-to-day execution of clinical trials from start-up through close-out.
• Own critical study coordination workflows such as maintaining trackers, decision logs, and training records.
• Ensure study documentation and training records are complete, current, and audit-ready.

Oura is a health technology company that produces the Oura Ring, a wearable device for tracking sleep, activity, and readiness. It is a quickly growing company with a mission-driven culture focused on employee well-being and innovation.

• Create, maintain, and control accurate versions of source documents for clinical trials following GCP and 21 CFR Part 11.
• Design e-Source and paper source templates based on protocol reviews and coordinate review and update processes.
• Manage version control, communication with site staff, and ensure source documents record all required trial data.

Care Access works to improve global health by bringing clinical research and health services directly to communities. They operate hundreds of research locations and mobile clinics worldwide, focusing on accessibility and community impact.

• Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
• Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.

• 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.

• 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.

• Support GCP/GCLP/GVP audits for investigational sites, internal systems, and clinical service providers, including planning, coordination, and reporting.
• Assist with commercial inspections, inspection readiness activities, and GCP compliance tasks such as investigations and change controls.
• Maintain a continuous improvement mindset and represent the Clinical Quality Assurance Team in cross-functional projects.

Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer patients. The company is a clinical-stage organization with a strong focus on innovation and collaboration in a fast-paced environment.

• Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
• Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
• Tracks study progress, manages budgets, and mentors junior clinical study managers.

Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.

• Ensures clinical trial databases meet project requirements by attending sponsor meetings and managing data management deliverables.
• Ensures proper execution of data management plans by collaborating with project team, defining edit checks, and maintaining documentation.
• Ensures accuracy and consistency of clinical databases by reviewing data, resolving issues, and tracking outstanding items.

Perceptive helps the global biopharmaceutical industry bring new medical treatments to market faster. With a global team, they emphasize collaboration, growth, and winning together.

• Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
• Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
• Ensure CTMs have proper resources and training to deliver high-quality study conduct.

Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.

• Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
• Coordinate all necessary activities to set up and monitor a study, including investigator identification, regulatory submissions, and pre-study/initiation visits.
• Identify potential study risks, propose solutions, and handle conflict using resolution strategies while maintaining quality and attention to detail.

Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational expertise, and biomarker analytics to advance oncology and rare disease treatments. The company fosters a culture with high CRA retention, small team influence, and a focus on work/life balance.

• Supports Quality Assurance Department clinical review activities and compiles documents for review requests.
• Collaborates with clinical staff and other departments to ensure comprehensive reviews and appropriate escalations.
• Reports on adherence to clinical quality standards and monitors payor Corrective Action Plans.

Centria provides clinical quality assurance services for autism therapy. They are an equal opportunity employer that values diversity and are large enough to support office operations across multiple states.

• Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
• Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
• Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.

• 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.

• Reviews patient data for Phase I-IV clinical research and non-interventional studies to ensure compliance with protocols and regulatory requirements.
• Communicates and escalates serious issues to the project team and develops action plans as needed.
• Maintains working knowledge of ICH/GCP guidelines and company SOPs, documenting activities per project requirements.

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are a global company with over 29,000 employees, dedicated to developing our people and building an inclusive culture.

• Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
• Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
• Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.

Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.