Source Job

• 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.

• Prepare month-end clinical and R&D accrual analyses, including reviews of CRO reports, patient costs, and site accruals, ensuring compliance with US GAAP and company policies.
• Maintain SOX controls, conduct variance analysis, and support internal and external reporting for timely and accurate financial statements.
• Work cross-functionally with Clinical Operations, Manufacturing, and R&D teams, and assist with annual audit documentation and process improvements.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, pioneering anti-FcRn technology to develop innovative targeted therapies. The company operates in a dynamic, interactive, fast-paced, and entrepreneurial environment with a focus on R&D accounting and cross-functional collaboration.

• 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.

• 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.

• 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.

• 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.

• 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.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
• Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
• Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.

• Conducts internal and external audits to evaluate financial, operational, and compliance controls.
• Analyzes data to detect deficient controls, fraud, or non-compliance and drafts recommendations for improvement.
• Communicates audit findings to corporate executive management through detailed reports.

Palmetto GBA is a healthcare service administrator providing technology solutions for healthcare administration. It is one of the nation's largest providers of medical claims processing and offers training and development programs for its associates.

• Acts as primary point of contact for investigative sites, providing training and support to ensure compliance with protocols and regulations.
• Conducts site evaluation, monitoring, and closure activities while managing recruitment and retention plans based on patient journey.
• Collaborates with central monitoring to assess risks and ensure data quality, safety reporting, and audit readiness at assigned sites.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, and neuroscience. It is a large pharmaceutical company with a global presence and a culture focused on remarkable impact.

• Oversee and manage OnPoint Audit SLG and other attest products for government and Yellow Book content.
• Collaborate with customers and internal teams to develop best-in-class workflows for state & local government audits.
• Stay current with evolving audit standards and proactively identify content improvements.

Caseware is a leading fintech company that provides audit and accounting software to over 500,000 users across 130 countries. With more than 30 years of industry experience and a customer-focused mindset, the company fosters a collaborative culture and values innovation.