Actalent Clinical Research Coordinator in Boston, Massachusetts
Actively looking to hire a Senior Clinical Research Coordinator to join a large CRO ON A PART TIME BASIS (20 hours a week) at the site level to help with clinical trials! This is a Monday to Friday; no weekends or holidays! Must be reliable and comfortable going onsite 3 days a week. This role is located in Boston, MA. Must have experience with EMR/EDC data entry and highly proficient in protocol comprehension, patient communication, and prescreening/scheduling patients.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs
Independently coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidential information and confidential information
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens
Create and execute recruitment strategies defined by Clinical Research Team
2+ years of Clinical Research Coordinator Experience
Experience with EDC Data Entry and patient recruitment
Can commit to 20 hours a week! - 2.5 days on site
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