Massachusetts Jobs

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.

Duties:

• 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

Qualiications:

• 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

• Reliable

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