Source Job

• 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.

• 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.

• 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.

• 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.

• Independently oversees all aspects of study site management to ensure patient safety is protected.
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.

Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

• 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.

• Work closely with the Principal Investigator to oversee the execution of study protocols and ensure site compliance with Good Clinical Practice.
• Be available to see subjects virtually or in-person, answer their questions, and resolve medical issues during the study visit.
• Perform trial procedures as per delegation, including prescreening candidates, obtaining informed consent, and administering questionnaires.

Care Access is dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.

• 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.

• Coordinate multiple related research studies at various stages of implementation.
• Oversee the implementation of community-based, mixed methods evaluation protocols, including data collection and management.
• Supervise research assistants and support data analysis and report generation.

Georgetown University is a leading research university with two unique campuses in Washington, D.C. Grounded in its Jesuit, Catholic identity, it is a diverse community devoted to social justice and respect for each person’s individual needs and talents.

• 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.

• Maintain full ownership and accountability for initiating phone contact to potential study participants.
• Conduct phone-based pre-screening interviews for potential study participants to determine pre-qualification status.
• Consistently provide outstanding customer service with every patient interaction.

M3 Wake Research is an integrated network of premier investigational sites meeting clinical research needs. They have close to 30 owned and managed research sites across the country and continue to grow through acquisitions.

• Conduct timely reviews of clinical trials relying on external IRBs or where Cooper serves as the reviewing IRB.
• Ensure research upholds ethical standards, complies with SOPs, and supports clinical trial start-up.
• Execute reliance agreements with support from the HRPP Director and Legal, when applicable.

Cooper University Health Care is committed to providing extraordinary health care. They are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols.

• 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.

• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
• Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing.
• Effectively oversees contracted vendors to ensure data are complete, accurate and delivered within agreed on timelines.

Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company, develops gene therapy as a new standard of care for ocular diseases. They are a clinical-stage company aiming to deliver therapies in physicians’ offices to eliminate the need for frequent ocular injections.

• Execute end to end project related tasks which include link setup, link testing, and set up and delivery of study invitations via custom tools.
• Manage and control of sampling for the allocated projects from the setup for internal invites to custom recruitment.
• Build a sampling plan for the projects allocated.

M3 is a Japanese global leader providing technological and research solutions to the healthcare industry. With over 5.8 million physician members globally, they operate in the US, Asia, and Europe.

• Manage and maintain accurate provider credentialing files and profiles.
• Support Clinical Operations including Provider communications.
• Coordinate full-cycle credentialing, re-credentialing, and insurance contracting.

SimpliFed is focused on providing maternal health services. The company appears to be a startup with a focus on innovation and improving women’s health.

• Responsible for executing clinical studies in compliance with quality standards.
• Supports the Study Project Manager in leading the cross functional study team.
• Supports the development of the clinical study blueprint/protocol and associated systems and documents.

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 including immunology, oncology and neuroscience.

• Take part in focus groups, clinical trials, online surveys/studies at home by following written and oral instructions.
• Participate in research focus groups. Each panel receives a complete written study.
• If products or services are provided, you must actually use them and give honest feedback.

The company seeks motivated individuals for data entry type work from home. It isn't clear how many people work there, but they seem to have a casual culture.

• Serve as leader of the local study team on assigned studies.
• Manage and maintain accurate country level plans including timelines and budgets.
• Implement startup and site activation plans at various levels.

Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly. They identify top-fitting candidates and shares this shortlist directly with the hiring company.

• Assist in contacting investigator sites to provide study specific information.
• Ensure receipt, completeness and accuracy of clinical and administrative documents.
• Coordinate distribution and shipment of study-related materials.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient.