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.
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.
Management and operational delivery of the clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of trial deliverables.
Identify challenges to study timelines/deliverables and offer creative action plans.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.
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.
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.
Recruit healthcare professionals for Qualitative and Quantitative projects.
Schedule respondents for interviews and confirm attendance.
Meet demanding deadlines and work on multiple assignments simultaneously.
M3 is a Japanese global leader providing technological and research solutions to the healthcare industry. They operate in the US, Asia, and Europe with over 5.8 million physician members globally and are publicly traded on the Tokyo Stock Exchange.
Perform discovery visits to access sites for research partnerships.
Provide protocol and product/procedural training to clinical sites.
Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
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.