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.
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.
Acts as a signatory for Harvard College on sponsored research documents and reviews awards for compliance with policies.
Negotiates terms and conditions for agreements like DUAs and awards, providing support for award management.
Communicates consistently with stakeholders and resolves issues with high-level judgment as an expert in research administration.
Harvard University is a vibrant community advancing world-changing missions through innovation and collaboration. The Harvard T.H. Chan School of Public Health is a world-renowned institution dedicated to public health research, education, and global collaboration, fostering a collaborative and inclusive work environment.
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Unlimited PTO
Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.
CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.
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.
Manages post-award activities for a portfolio of grants and contracts using knowledge of grant management rules and regulations.
Interacts regularly with faculty, ensures adherence to policies, and solves problems related to post-award activities.
Coordinates budget adjustments, financial reporting, and compliance monitoring through the lifecycle of awards.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We are a large academic institution committed to equal opportunity and diversity.
Support implementation and operation of the Compliance Program, including conflict of interest, compliance hotline, and regulatory reviews.
Serve as liaison for compliance questions and incidents, and recommend corrective actions and education opportunities.
Work with all levels to ensure internal controls provide accurate, complete, and compliant processes.
Cooper University Health Care is a healthcare organization dedicated to providing extraordinary health care and fostering clinical innovation. It offers competitive compensation, comprehensive benefits, and opportunities for professional growth.
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.
Review assigned TEFCA directory entries against authoritative corroboration sources and apply the approved review methodology.
Research, validate, and reconcile healthcare directory data across multiple reference sources, documenting findings in Jira.
Classify entries using a four-tier disposition taxonomy and escalate exception-path entries to the Lead Analyst.
Broadway Ventures is an 8(a), HUBZone, and Service-Disabled Veteran-Owned Small Business (SDVOSB) that provides expert program management, technology, and consulting solutions to government and private sector clients. As a small business, they emphasize integrity, collaboration, and excellence in their tailored solutions.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Manage day-to-day project operations as principal investigator, project director, or task lead, ensuring high-quality deliverables.
Lead collaborative teams by developing timelines, coordinating staff, and overseeing budgets.
Apply subject-matter expertise to design and implement rigorous research studies and communicate findings to clients.
AIR is a nonpartisan, not-for-profit institution conducting behavioral and social science research and delivering technical assistance to solve urgent challenges in the U.S. and globally. Established in 1946 with headquarters in Arlington, Virginia, AIR generates evidence and data-driven solutions to expand opportunities and improve lives.
Schedule and prioritize agenda items for monthly IRB meetings, pre-briefs, and board sessions.
Draft meeting minutes, track action items, and maintain governance documentation such as charters and policies.
Administer the IT Governance SharePoint site, support budget reviews, and prepare executive-level presentations.
Raye IT Consulting, LLC is an 8a certified minority woman-owned IT consulting and technology firm with over 20 years of experience delivering mission-critical programs for the Federal Government. The company specializes in program management, capital planning, and IT operations, with a focus on innovation and measurable results.
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.
Coordinate proposal compliance activities, tracking deadlines and documentation across the proposal lifecycle.
Maintain compliance checklists, trackers, and document management platforms for team visibility and accountability.
Support proposal preparation through document formatting, quality checks, and final submission readiness.
Jobgether uses an AI-powered matching process to connect candidates with roles at partner companies. They focus on efficient, fair recruitment and process applicant data in compliance with data protection laws.
Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.
Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.
Manage day-to-day project operations as principal investigator or project director, ensuring deliverables are on time and within budget.
Design and implement rigorous applied research studies, including aligned research questions, methodologies, and analytic plans.
Lead proposal development and build strong client and stakeholder relationships.
American Institutes for Research (AIR) is a nonpartisan, not-for-profit organization that conducts behavioral and social science research and delivers technical assistance to address pressing challenges. Founded in 1946 and headquartered in Arlington, Virginia, AIR employs a multidisciplinary team of economists, data scientists, public health experts, clinicians, and policy researchers, fostering a collaborative and evidence-driven culture.
Manage international quantitative market research projects through the entire project life cycle, including client and vendor management and healthcare professional sample.
Coordinate project kickoff meetings, monitor data collection productivity, and manage study profitability.
Partner with sales and operations teams to improve performance and support international teams outside US business hours.
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since 2000, the company has experienced remarkable growth, fueled by its mission to use the internet for a healthier world, with a dynamic and innovative work environment where every team member contributes to global health advancements.
Develop client-ready deliverables including protocols, statistical analysis plans, and technical reports.
Manage the delivery of project components by collaborating with other staff members.
Contribute to development of proposals and presentations under guidance of senior team members.
Precision Medicine Group is a portfolio organization that helps its clients with sophisticated evidence synthesis projects. The company has a start-up culture with vision in its field.
Support Omada’s research program by coordinating day‑to‑day study operations for assigned protocols.
Contact study participants to facilitate timely, complete and accurate participation in study.
Maintain accurate study documentation and trackers so the team has a current view of study status.
Omada Health is reverse engineering the way healthcare is delivered in America, putting the space between doctor visits at the center of care. Omada has served more than two million members since launch across 2,000+ employers and strives to build an inclusive culture.
Own end-to-end planning and execution of standardized assessments for assigned programs, ensuring compliance and successful delivery.
Serve as subject matter expert on testing requirements, platforms, and protocols, managing scheduling, proctor readiness, and live events.
Analyze participation trends, oversee score reporting, and drive process improvements through post-assessment retrospectives.
OpenEd opens the world to every learner, serving over 100,000 students with customized education. With an eNPS in the top 0.1% of tech companies, they have a strong culture focused on customer obsession, action, and transparency.
Monitor and interpret CMS guidance for Medicare, Medicaid, and other healthcare programs.
Partner with internal teams to ensure compliance with regulations and contract obligations.
Maintain regulatory tracking documentation and support development of training materials.
HealthEdge provides healthcare software and services to payers and providers. It is a growing company with a focus on compliance and innovation, fostering a collaborative and remote-friendly culture.