Source Job

• Coordinate day-to-day clinical trial operations remotely, ensuring compliance with study protocols and regulatory guidelines.
• Support and facilitate remote patient visits, including scheduling, documentation, and follow-up.
• Maintain accurate and timely data entry in EDC and CTMS systems and manage query resolution.

UniTriTeam is a global leader providing operational, administrative, and technology support to clinical research sites. They take pride in their mission to help advance medicine and make a real impact in healthcare, fostering a collaborative and supportive work environment.

• Support compliant document management and record-keeping.
• Manage schedules, including calendar management and travel arrangements.
• Assist with the preparation of presentations and materials as needed.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company with an innovative culture.

• Conduct all participant facing tasks, ensuring a positive trial experience and excellent data accuracy within our platform.
• Oversee data collection and in-person processes, maintain participant trackers, and assist with day-to-day trial implementation.
• Collaborate effectively with trial teams to ensure seamless participant experiences and contribute to process improvements.

Lindus Health uses software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. It is a young, VC-funded startup with a collaborative, no-ego culture where team members take on real responsibility and work across different areas.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
• Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
• Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.

Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.

• Providing administrative support to the team, supporting preparation and collection of documentation.
• Creating, updating and managing activities within internal systems, supporting supplier onboarding.
• Tracking, reporting and managing data across tools and dashboards.

Smartway Energy Ltd is looking for an Administrative Assistant to provide high-quality administration and organizational support to the Senior Management Team. The company seems to be a growing organization.

• Support site initiation, management, and close-out activities.
• Ensure trial conduct complies with protocol and regulatory requirements.
• Participate in data review and support site readiness.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease by staying true to their values and innovating boldly.

• Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs).
• Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people's lives across several key therapeutic areas. For more information about AbbVie, please visit them at www.abbvie.com.

• Respond to client inquiries and provide timely updates on prescription status
• Monitor prescription workflows and proactively flag delays or discrepancies
• Assist with reshipments and coordinate issue resolution with internal teams

Precision Medicine is revolutionizing healthcare by providing accessible, personalized, and efficient healthcare solutions. They value diverse perspectives and foster an environment where employees can thrive, innovate, and make a meaningful impact on patients’ lives.

• Responsible for managing research activities at sites participating in Worldwide’s clinical research projects.
• Involved in all stages of the clinical study, including identifying potential sites and performing study start-up activities.
• Conduct study initiation visits and ensure compliance with informed consent and reporting potential safety events.

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents to cure the world’s most persistent diseases. They are a global team of over 3,500+ experts, bright thinkers, dreamers and doers that are changing the way the world experiences CROs.

• Provide administrative and programmatic support for a VA Research Office
• Process research proposals involving the use of animal subjects and the use of hazardous biological or chemicals in medical research
• Support the Research Office to conduct audits of regulatory documents

Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations, and enhanced service delivery. Founded in 2012, they have 300+ employees nationwide and specialize in applying technology, creativity and human-centered services.

• Act as a central contact for Clinical Study Teams for TMF management and participate in the development of quality oversight processes for TMF management of clinical trials.
• Review and approve TMF documents, co-author and manage TMF documents such as TMF Plan and Index, and ensure quality management by reporting metrics and reconciling outstanding queries.
• Oversee the activities of external vendors, ensuring study documents are adherent with ICH-GCP guidelines and regulatory requirements and that assigned studies are inspection-ready.

Oruka Therapeutics develops novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. It is a growing biotech startup building its core team with an engaged, inclusive, and positive company culture focused on making a difference.

• Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.

• Lead project teams to ensure efficient execution of clinical trials.
• Manage day-to-day project operations while adhering to timelines and budgets.
• Coordinate team activities and resources for optimal project delivery.

Jobgether uses an AI-powered process to ensure applications are reviewed quickly and fairly against the role's core requirements. They identify top-fitting candidates and share this shortlist with the hiring company.

• Provide administrative and programmatic support for research and program offices.
• Support various research committees and initiatives, which may include the Subcommittee on Research Safety (SRS), the Institutional Animal Care and Use Committee (IACUC), and the Research and Development (R&D) Committee.
• Process research proposals involving the use of animal subjects and/or hazardous biological or chemical materials in medical research, including receipt, logging, routing, tracking, inquiry, evaluation, review, action and response.

Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. It was founded in 2012 and has 300+ employees nationwide, specializing in technology, creativity and human-centered services.

• Independently coordinates assigned study activities in accordance with study protocols, SOPs, and applicable regulatory requirements.
• Screens potential research participants for eligibility, documents inclusion/exclusion determinations, and escalates complex eligibility questions as needed.
• Manages scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities with minimal supervision.

Synapticure provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support in all 50 states through a virtual care platform. Partnering with providers and health plans, including CMS' new GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer’s, Parkinson’s, and ALS.

• Manage program tracking systems.
• Support communication workflows.
• Maintain organized documentation.

Aptive partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. Based in Alexandria, Virginia, they support more than a dozen agencies including Veterans Affairs, Transportation, Defense, Homeland Security and the National Science Foundation and have 300+ employees.

• Regularly engage with patients and track their adherence to their care plans.
• Closely monitor your patients' device readings and dig into any out-of-bound values.
• Maintain meticulous records of patient interactions, and program details.

Medsien is a leading provider of scalable remote care management, enabling healthcare practices to enhance patient engagement, improve outcomes, and optimize operational efficiency. Hundreds of organizations trust Medsien’s unparalleled technology solutions to implement exceptional remote care management programs, personalize every interaction, and improve the lives of those who need it most.