Responsible for preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manages site start-up activities including essential document collection, informed consent form review, and coordination with investigators and contracts.
Acts as a subject matter expert for regulatory submissions and may support process improvement, training, and mentoring.
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.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Monitor and own the progress of clinical studies at investigative sites.
Ensure studies are conducted per protocol, SOPs, ICH-GCP, and all applicable regulations.
Coordinate setup activities including investigator identification and regulatory submissions.
Precision for Medicine is a CRO integrating clinical trial execution with scientific and lab expertise, focusing on Oncology and Rare Disease. They have a strong culture with high CRA retention and emphasize work-life balance.
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.
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.
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.
Lead site activation strategies and oversee start-up activities across clinical studies.
Manage critical path plans and mitigate risks to ensure timelines are met.
Collaborate with cross-functional teams and clients to improve activation processes.
Our partner is a clinical research organization that supports the delivery of clinical trials. They are a global company with a collaborative culture focused on innovation and operational excellence.
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.
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 regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
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.
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.
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.
Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
Represent regulatory on study teams and maintain knowledge of US and international regulations.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.
Support feasibility and study start-up activities for clinical research sites in Romania and Moldova, coordinating documents and site communication.
Maintain accurate trackers in Salesforce and Asana, flagging blockers and delays early to ensure timely site activation.
Serve as a day-to-day operational contact for sites, routing questions to appropriate internal, CRO, or sponsor contacts.
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The company has 250+ employees worldwide and is headquartered in Cambridge, Massachusetts, and New York City, with a collaborative and low-ego team environment.
Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.