Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
Oversee the execution of Site Activation, site activation strategy, adhering to project timelines.
Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.
Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, they focus on ensuring every person has the opportunity to understand their health and access the care they need.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. 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.
Facilitating negotiations of site agreements and budgets to ensure alignment with the site activation plan.
Customizing and preparing country- and site-specific agreements and organizing their translations.
Tracking the status of site agreement and budget negotiation.
They are a company that cares for their staff, clients, partners and the quality of their work. A dynamic, global company founded in 1995, they bring together more than 3000 driven, dedicated and passionate individuals, working on the front line of medical science, changing lives, and bringing new medicines to those who need them.
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.
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.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
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.
Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site.
Customize and prepare contractually binding site-specific documents in cooperation with PSI Legal.
PSI is a leading Contract Research Organization with 30 years in the industry. They offer a perfect balance between stability and innovation to both clients and employees, focusing on delivering quality and on-time services across a variety of therapeutic indications.
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.
Serve as the subject matter expert and primary escalation point for global site contracts, budgets, and payments
Lead development of investigator grant budgets, payment terms, and contracting strategies
Oversee contract tracking, documentation, and compliance across internal systems and external partners
Deciphera is committed to equal employment opportunity and values diversity. They provide a competitive compensation and benefits package to all employees and believe in personal and professional growth.
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.
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Serves as the clinical trial lead responsible for the planning, conduct and oversight of clinical studies.
Develop study related clinical documents and generate potential site list from key stakeholders.
Manage processes for investigational product including drug accountability and reconciliation.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the speed, cost and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease, providing deep scientific knowledge.
Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management.
Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
Identify risks and propose solutions to facilitate clinical studies.
Nuvalent is working to create selective medicines designed to address the needs of patients with cancer. They are an exciting early-stage company with experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.