Source Job

• 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.

• 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.

• 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.

• 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.

• Develop safety management plans and oversee serious adverse event case management from intake to regulatory reporting.
• Perform intake, triage, data entry, medical coding, and narrative composition for individual case safety reports.
• Provide safety training, review standard operating procedures, and assist clients with safety-related reviews.

Precision Medicine Group is a global contract research organization specializing in clinical research and drug development services. The company fosters a collaborative culture and offers competitive benefits to support employee growth.

• Process individual case safety reports (ICSRs) for clinical trials and post-marketing programs.
• Ensure accurate data entry, coding, and query resolution in the Argus Safety Database.
• Collaborate with cross-functional teams to meet regulatory reporting requirements and maintain compliance.

Precision Medicine Group is a global life sciences company specializing in precision medicine and drug development services. They employ thousands of professionals and emphasize a collaborative culture.

• 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 safety contract service organizations (CSOs) to ensure ≥95% compliance with global safety regulations and corporate KPIs.
• Oversee AE intake from global data sources and prepare assessments of safety data for internal leadership and regulatory authorities.
• Maintain audit trail as inspection-ready at all times and direct participation in agency inspections (FDA, EMA, Health Canada, etc.).

BridgeBio Pharma pioneers a pooled risk model for biotech, advancing early-stage research to develop life-changing medicines for rare diseases. They are a multi-state employer with a culture of curiosity, experimentation, and high expectations for their team members.

• Acts as primary point of contact for trial-specific medical and safety questions, providing input to regulatory authorities and ethics committees.
• Monitors participant safety, reviews protocol deviations and RAE reports, and supports pharmacovigilance with safety queries.
• Participates in trial recruitment, investigator meetings, and reviews clinical study reports and essential trial documents.

PSI is a leading Contract Research Organization with over 30 years in the industry, focusing on delivering quality and on-time services across various therapeutic indications. They offer a balanced and stable yet innovative environment for employees, with an international team of medical professionals.

• Lead and manage all drug safety functions for investigational products across the organization.
• Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
• Collaborate cross-functionally to ensure compliance and advance patient safety.

BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.

• Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
• Identify common tasks and problems where AI can add value in pharmacology workflows.
• Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.

Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.

• 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.

• 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.

• Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
• Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
• Provide medical oversight of safety data and contribute to benefit-risk assessments.

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
• Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
• Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.

Deciphera is a biopharmaceutical company focused on developing kinase inhibitor therapies for cancer. The company offers a competitive compensation package and promotes a culture of personal and professional growth.

• Co-own Tiny Health's clinical evidence roadmap and define study objectives aligned with product and regulatory goals.
• Lead the design and publication of observational, interventional, and real-world evidence studies, including protocol development and statistical analysis plans.
• Partner with cross-functional teams to ensure analytical rigor, translate findings into defensible claims, and present results to internal and external audiences.

Tiny Health advances lifelong health through precision microbiome science, addressing chronic disease from the first 1,000 days to the last. Founded in 2020 by microbiome scientists and physicians, the company is a remote-first team of about 30-50 employees with a culture of high standards, transparency, and continuous learning.

• Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
• Develops study documents, manages site feasibility, and drives recruitment strategies.
• Leads internal clinical team meetings and ensures quality deliverables through metric reporting.

Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.

• 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.

• Provide clinical development leadership at the study level for clinical stage assets in early and/or late development.
• Serve as medical monitor for one or more studies and perform ongoing clinical trial data review.
• Contribute to clinical development strategy and author clinical and regulatory documents.

Deciphera is a biopharmaceutical company focused on developing new medicines to improve the lives of people with cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.