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.
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.
Provide leadership and high-level technical support for research compliance, including reviewing human subjects research submissions and non-research determinations.
Support project teams with data management plans and ensure compliant closeout of learning activities.
Collaborate with the IRBhelp team to ensure timely review and feedback on submissions.
Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.
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.
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.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.
Responsible for site activation readiness, including preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees.
Manage collection of essential documents, customize informed consent forms, and coordinate translations for study-specific documents.
Maintain communication with key functions (Feasibility, Clinical Operations, Regulatory) and update project trackers and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization focused on precision medicine, combining novel clinical trial designs and advanced biomarker solutions, particularly in rare diseases and oncology. The company is growing and seeks dedicated professionals to support its mission, fostering a culture where employees feel appreciated and their ideas valued.
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.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
Serve as subject matter expert defining gold standard for AI-generated clinical content.
Share knowledge about day-in-the-life working with data for regulatory submissions.
Identify realistic sources of variance or data corruption in study data.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a small team of top researchers and engineers across AI and biology to build an AI scientist.
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.
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.
Identify, recruit, educate, and pre-screen potential patients for clinical studies.
Maintain up-to-date information across multiple study portals and prioritize data entry and clean-up.
Attend meetings with principal investigators and site teams to review progress and resolve issues.
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.
Provide administrative and operational support to project teams throughout the clinical research project lifecycle.
Coordinate meeting logistics, documentation, and stakeholder communications to ensure smooth execution.
Assist with data entry, report generation, and compliance with regulatory requirements.
This partner company provides clinical research project management services to clients globally. They offer a fully remote, collaborative work environment focused on quality and continuous improvement.
Draft, review, and negotiate clinical site agreements and related documents to ensure compliance with regulatory standards.
Manage the full contract execution process, including tracking timelines, resolving issues, and coordinating signatures.
Act as a key liaison between internal teams and clinical sites, ensuring clear communication and adherence to budgets and regulations.
Our partner is a company in the life sciences industry focused on clinical trial execution and regulatory compliance, contributing to the development of life-changing therapies. The environment is collaborative, quality-driven, and fast-paced, with a strong emphasis on accuracy, communication, and professional growth.
Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.
Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.
Independently negotiate and manage complex clinical trial agreements, site budgets, and amendments with minimal training.
Partner cross-functionally with Clinical Operations, Finance, and Legal to ensure compliant and timely study startup.
Serve as subject matter expert and escalation point for contract and budget issues across global studies.
CareDx is a leading precision medicine solutions company focused on improving outcomes for transplant patients through innovative diagnostics, services, and digital health solutions. As a leader in genomics-based transplant information, the company offers a competitive Total Rewards package and fosters a mission-driven culture where employees directly impact patient 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.