Source Job

• 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.

• 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.

• Deals directly with internal and external customers via telephone and electronic channels to obtain missing information needed for processing of submitted test samples based on assigned region.
• Communicate test status per protocol to respective customers, resend and/or request the resending of issued test results and Schedule requests for mobile phlebotomy.
• Respond promptly to internal and external customer inquiries and complaints regarding missing and delayed test samples, results reports, and other relevant inquiries.

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.

• 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.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate activities to set up and monitor a study.
• Train and mentor junior staff members.

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the success rate of therapies for patients. They cultivate their culture and have high CRA retention rates compared to industry averages.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

• 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.

Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.

This position is posted by Jobgether on behalf of a partner company.

• Designing, configuring, testing, and supporting eDC systems that meet the data collection needs of study protocols.
• Influencing study design, data capture, and compliance with Good Clinical Practice (GCP) standards and FDA/CVM regulations.
• Maintaining thorough documentation, validation reports, and data dictionaries.

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Loyal's team includes scientists, veterinarians, engineers, operators, and creatives, and they are a well-funded startup in growth mode.

• 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.

• Perform on-site monitoring visits and ensure site compliance with regulatory requirements and Good Clinical Practice.
• Ensure site maintains an accurate inventory and accountability of investigational drug and clinical supplies.
• Facilitate resolution of problems, queries and action items.

Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases.

• Assist with the development of the protocol and informed consent form and/or program design.
• Manage vendor budgets, payments, and timelines.
• Effectively track and report on internal project metrics and study progress.

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.

• 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.

• 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.

• Responsible for implementation and support of applications and works with end users to troubleshoot and correct problems.
• Researches and evaluates a variety of solutions to provide end users with high quality, efficient products.
• Participates in the planning, development, implementation, maintenance, support and evaluation of clinical or business application systems.

The University of Kansas Health System is a world-class healthcare provider and destination for complex care and diagnosis. They are driven by their commitment to service, continuous improvement and to the highest degree of excellence.

• 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.

• Collaborate with cross-functional teams to develop clinical documents for dermatology-related trials.
• Contribute scientific input and implementation into study design and execution.
• Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis.

• Drive collaboration and coordination with cross-functional teams.
• Track team progress and deliver detailed status reports, including KPIs and performance data.
• Audit call and email communications to assess quality and accuracy; compile QA feedback summaries for management and training teams.

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.

• Prepare and follow through on bids for new business.
• Oversee financial and contractual performance of Sponsor projects.
• Maintain a strong relationship with the customer during an ongoing clinical trial.

Jobgether is a platform that connects job seekers with potential employers. The company uses AI-powered matching to ensure applications are reviewed quickly and objectively.