Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.
Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.
Independently oversees study site management, ensuring patient safety and data quality.
Manages site start-up procedures, including feasibility, regulatory submissions, and document review.
Conducts site visits, prepares reports, and communicates with site personnel and project management.
Precision for Medicine integrates new technologies, expertise, and operational scale to improve the speed, cost, and success rate of life-changing therapies. They integrate clinical trial execution with scientific knowledge, lab expertise, and data sciences with a focus on Oncology and Rare Disease.
Directs the operational oversight and execution of clinical site start-up.
Manages CRO relationship and oversight to ensure appropriate scope of work.
Develops collaborative relationships with investigative sites.
Bristol Myers Squibb is focused on developing innovative drugs against targets of solid tumors. They are a dynamic biotechnology company headquartered in San Diego, CA, and aim to be the global leader in radiopharmaceuticals.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Develop, review, and update study-related training materials and documents.
Serve as Subject Matter Expert for clinical sites and provide guidance on protocol interpretation and eligibility requirements.
Partner with field Clinical Research Associates (CRAs) and CTAs to resolve issues identified during site visits.
ImmunityBio is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to strengthen the immune system to eliminate cancerous or infected cells. They are publicly traded with headquarters in Southern California, working collaboratively to transform the lives of patients.
Accountable for study level tracking as assigned by the Clinical Project Manager.
Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Collaborate with dedicated research sites contributing to rare neurological disease research.
Make a significant impact in the scientific community alongside a dedicated team of CRAs.
Encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits.
St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital providing health, social, and support services. They are dedicated to caring for the poor and underserved, and are known for quality quaternary care, medical education, and research.