Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
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 plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.
Monitor clinical studies of investigational and approved products.
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
Review data queries and listings, and work with the study centers to resolve data discrepancies.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They believe great work happens when team members feel valued, supported, and empowered, and they are committed to making a meaningful impact on global health.
Manage administration of the Rave URL activities: Report Administration, eLearning, User Roles and Core Configuration.
Lead development of study database, including programming of clinical database according to CRF Specifications.
Support global library by programming forms and edit checks according to data collection standards.
Jobgether is a platform that uses AI to match candidates with jobs, ensuring a quick and fair review process. They provide a supportive team culture and collaboration.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
Responsible for assisting in carrying out basic clinical data management activities for assigned projects. Focus on data integrity, validity, reliability in accordance with standard processes. Support the department and company in achieving objectives and strategic goals.
Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media.
The Director of Clinical Development leads the team responsible for design, execution, and strategic direction of clinical programs across Loyal’s veterinary product portfolio. This role drives end-to-end clinical strategy, from target product profile to study design and regulatory-facing protocol development through field execution, data interpretation, and evidence package generation. This is a highly cross-functional role that partners closely with Veterinary Affairs, Clinical Operations, Regulatory (FDA-CVM),CMC, and Commercial.
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs.
Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.
Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.
Serve as an SME for the clinical functionality of the EHR system.
Develop and deliver targeted training programs for new and existing clinical staff on EHR use.
Act as the clinical liaison to the Product and Technology teams, translating real-world workflow needs into technical specifications for new features or enhancements.
Synapticure is a patient and caregiver-founded company that provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support through a virtual care platform. Partnering with providers and health plans, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases.
Identifies MCS Program patients and abstracts and enters clinical data into defined patient registries.
Focuses primarily on accurate and timely data abstraction and data review in alignment with the Trauma Registrar scope.
Maintains data accuracy through quality checks and supports compliance with all standards.
Legacy's mission is to make life better for others, and they carry out that mission in everything they do. They rely on individuals who are experts in their field and who view their work as vital to the overall success of the healthcare community.
Support daily operations of study coordinators and clinical staff, escalating challenges and suggesting solutions.
Assist in documenting processes and workflows to simplify daily work and focus on patients.
Provide system and process support to team members, answering questions and assisting with training.
Care Access aims to improve the future of health for everyone. They bring research and health services to communities through research locations, mobile clinics, and clinicians across the globe.
Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.
Manages central laboratory and specialty vendors across clinical trials.
Provides support for sample related matters to clinical study teams.
Assists with vendor selection and oversight.
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate all necessary activities required to set up and monitor a study.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.
Assist with daily site activities, acting as the primary point of contact for the site.
Assist with training and mentoring research staff, upholding professional development goals.
Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.
Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.
Oversight for traveling clinical staff supporting decentralized operations at events and sites.
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).
Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.
Performs cancer registry duties related to completion of abstracts for benign and malignant processes for the cancer database. Complies with the established standards of Commission on Cancer, Georgia Cancer Registry, and the Piedmont Cancer Committee. This is a remote position.
Join Piedmont to move your career in the right direction and be recognized for your contributions to exceptional patient outcomes.