Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Engage with patients to recruit, educate, and pre-screen them for clinical studies.
Maintain data accuracy across multiple study portals and manage data entry and queries.
Collaborate with site teams and PIs to ensure protocol compliance and resolve issues.
Care Access brings world-class research and health services directly to communities, working to make the future of health better for all. With hundreds of research locations and a global team, we are dedicated to ensuring every person can contribute to medical breakthroughs.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Manage end-to-end IRB meeting workflows, including submissions, reviewer assignments, and meeting preparation.
Facilitate communication among client services, IRB Chairs, Board members, and clients to ensure timely review processes.
Prepare and review informed consent forms for regulatory compliance and quality.
The company coordinates Institutional Review Board (IRB) meetings within a highly regulated clinical research environment. They offer a collaborative and inclusive culture focused on ethical, patient-centered outcomes, though company size is not specified.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Manage clinical study vendors and ensure deliverables are on time, within budget, and compliant with FDA and ICH/GCP guidelines.
Support CRO collaboration, site start-up, study documentation, and risk mitigation with cross-functional teams.
Leverage AI tools and process improvements to enhance clinical operations productivity and quality.
This biotechnology company focuses on developing innovative oncology therapies. It offers a collaborative, multidisciplinary environment with opportunities to use AI-enabled tools and modern approaches to clinical operations.
Prepare and maintain Trial Master Files for clinical studies, ensuring completeness and compliance.
Review documentation for accuracy and alignment with protocols and regulations.
Communicate with sponsors, project managers, and sites to resolve documentation issues.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They foster an inclusive, collaborative, and respectful workplace, utilizing technology to ensure fair recruitment.
Lead clinical trial strategies and evidence-generation plans supporting global regulatory submissions.
Design and oversee clinical protocols, claims, and evidence strategies in collaboration with internal and external stakeholders.
Serve as a scientific liaison with regulatory authorities and mentor junior scientists to drive clinical excellence.
The company develops diagnostic products for the US and EU markets, focusing on generating robust clinical evidence for regulatory submissions. It maintains a remote-first culture with a collaborative, cross-functional environment and opportunities for scientific leadership.
Support identification and tracking of pipeline opportunities in clinical imaging.
Coordinate proposals, client requests, and commercial documentation.
Maintain CRM records and assist with pricing and sales operations.
The company operates in the clinical imaging and clinical trials space, supporting the generation of high-quality clinical evidence. It offers an inclusive and collaborative global work environment with a focus on professional growth.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.
Conduct clinical audits and risk assessments to identify compliance gaps.
Manage multiple client engagements and deliver accurate project results.
Build strong client relationships and present findings to leadership.
Kodiak Solutions transforms healthcare through technology-driven solutions, specializing in finance, unclaimed property, and risk management. Their innovative platform streamlines operations, allowing providers to focus on patient care.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
Manage multiple priorities and ensure file structure and indexing are accurate.
Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.
Lead medium- to high-complexity clinical trials with full accountability for timelines, budgets, resources, and quality.
Oversee financial performance, risk mitigation, and quality standards while ensuring regulatory compliance.
Mentor Project Leaders and represent project leadership in client meetings, bid activities, and conferences.
A clinical research organization managing complex clinical trials and therapies. It fosters a fast-paced, collaborative environment focused on innovation, accountability, and professional development.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Edit and review informed consent forms to ensure regulatory compliance and clarity.
Collaborate with IRB members, sponsors, and sites to incorporate required language.
Mentor junior editors and contribute to process improvements for quality control.
The partner company provides specialized services for clinical research and regulatory compliance. It fosters a collaborative environment and emphasizes ethical research practices, though team size is not specified.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Assist in planning and implementing clinical research protocols including subject screening and enrollment.
Collect, organize, and analyze research data; assist with specimen collection and lab processing.
Support manuscript preparation, IRB submissions, and grant proposals.
OHSU is Oregon's only public academic health center, providing patient care, groundbreaking research, and training for healthcare professionals. As Portland's largest employer, it offers opportunities for growth across a diverse system of hospitals and clinics.