Support and observe clinical site monitoring services inhouse.
Provide monitoring and site management activities for full-service studies.
Conduct remote data review, support data query and closure activities.
Alimentiv is a global contract research organization (CRO) providing clinical trials and research services. While the employee count is not provided, they appear to foster a collaborative environment.
Responsible for operational oversight of the site, site health and monitoring activities.
Support sites in understanding study expectations, timelines, and required deliverables.
Build and maintain strong, trusted relationships with investigators and site staff.
CSL Behring is a global biotherapeutics leader committed to saving lives. They focus on serving patients’ needs by using the latest technologies to discover, develop, and deliver innovative therapies. CSL's parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Monitor and own the progress of clinical studies at investigative sites.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease and passionate about cultivating their culture with high CRA retention rates.
Ensures complete study scoping, including testing requirements, facilities and other nuances.
Provides technical details to study team for study designs and updates.
Conducts investigations and assists with implementation of corrective actions, as needed.
ACM Global Laboratories impacts patients and their families by being purposefully patient-driven. Their dedication is reflected in the high-quality work provided by their teams every day around the globe.
Provide strategic and administrative leadership for clinical research business and operational activities.
Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
Drive operational performance, program growth, and team development across the clinical research enterprise.
Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.
Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.
Oversight of site level tasks associated with efficient site activation.
Support the CRA team in preparing for site initiation visits (SIVs).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.
Providing unbiased medical guidance to clinical sites and study operations teams.
Offering therapeutic and compound training and medical guidance on protocol compliance.
Ensuring medical congruency at the subject and study level and oversight of medical terms.
Alimentiv is a company that provides unbiased medical guidance to clinical sites and internal and external study operations teams. They focus on therapeutic and compound training, medical guidance on protocol compliance, and ensuring medical congruency.
Assisting in the management of cross-functional sub teams to facilitate timely planning, execution, tracking, and completion of NDA-related clinical deliverables.
Setting up meetings, drafting agendas and detailed minutes, and tracking actions through completion.
Assisting in the identification of issues impacting plan execution and working with the team to identify risks and develop mitigation strategies
Amylyx is dedicated to ushering in a new era for treating diseases with high unmet needs. They value urgency, rigorous science, and unwavering commitment, demonstrated by their experienced team ready to take action.
Leads the Clinical Study Team for assigned projects from concept to protocol.
Manages external vendors and contract research organizations.
Manages operational activities at the study level and monitoring activities at clinical study sites to assure adherence to GCP, SOPs, and study protocols.
BridgeBio is committed to discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases with unmet needs. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Engage with KOLs and external experts to discuss clinical data, emerging research, and disease-state insights
Support investigator-initiated and company-sponsored studies and represent the company at scientific meetings and congresses
Deliver clear, balanced scientific presentations and communicate field insights to internal stakeholders
Deciphera is committed to fair and equitable compensation practices. Deciphera believes in providing a competitive compensation and benefits package to all employees and values diversity.
Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site.
Customize and prepare contractually binding site-specific documents in cooperation with PSI Legal.
PSI is a leading Contract Research Organization with 30 years in the industry. They offer a perfect balance between stability and innovation to both clients and employees, focusing on delivering quality and on-time services across a variety of therapeutic indications.
Maintain project documentation including presentations, plans, agendas and overall project timelines.
Act as the primary liaison between technical teams and external partners to ensure alignment on project goals.
Provide proactive communication by setting clear expectations and providing project updates before client requests.
Medrio seeks smart and capable individuals to expand product capabilities, grow their business, and better serve customers. They value collaboration, ingenuity and creating a culture of excellence, offer great benefits and promote an atmosphere of work/life balance, including flexible work schedules and locations.
Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
Oversee the execution of Site Activation, site activation strategy, adhering to project timelines.
Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.
Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, they focus on ensuring every person has the opportunity to understand their health and access the care they need.
Guide field CRM implementation and maintenance with CRM implementation vendor.
Manage field alignment including field roster, zip to terr, HCO/HCP targeting and alignment.
Coordinate/manage sample operations and logistics with sampling vendor and field colleagues.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are headquartered in Radnor, Pennsylvania and are a fully remote company.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications.
Trains investigational site staff as necessary.
Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility, creative contribution and realistic career development.