Clinical Research Coordinator - Contract - Denver CO
Are you ready to drive the future of clinical operations from behind the scenes? Looking to be in the heart of a company where precision meets purpose?
À±½·ÊÓƵ is seeking a Clinical Research Coordinator II to oversee the daily operations and management of assigned clinical trials.
Primary Responsibilities:
This role involves administrative duties, regulatory compliance, and collaboration with various stakeholders, including study sponsors, monitors, CROs, and site management. You will also play a key role in training and guiding junior team members while ensuring adherence to protocols and regulatory standards.
Skills & Requirements:
- Experience in clinical research, with a strong understanding of regulatory compliance and protocols.
- Proficiency in data collection, documentation, and electronic data capture systems.
- Strong organizational skills to manage study supplies, schedules, and documentation.
- Ability to perform medical procedures such as vital signs, ECGs, and specimen collection.
- Effective communication skills for interacting with patients, investigators, and study sponsors.
- Problem-solving skills to address protocol deviations and operational challenges.
- Commitment to maintaining confidentiality and ethical standards.
The Clinical Research Coordinator's responsibilities will be:
- Manage and oversee clinical trial enrollment, identifying strategies to exceed recruitment goals.
- Collaborate with recruitment teams and site management to optimize recruitment practices.
- Educate patients or caregivers about study procedures and requirements.
- Monitor study activities to ensure compliance with protocols and regulatory guidelines.
- Maintain and update study e-regulatory binders, ensuring all documentation is accurate and complete.
- Schedule study visits and monitor timelines according to protocol requirements.
- Collect and document data during patient visits, ensuring accuracy and timely entry into electronic data capture (EDC) systems.
- Address and resolve data queries within specified timeframes.
- Manage inventory of lab and study supplies to meet study needs.
- Attend investigator meetings and site initiation visits, gathering relevant study information.
- Perform protocol-specific procedures, such as vital signs, electrocardiograms, and specimen collection.
- Record and report adverse events, collaborating with investigators as needed.
- Ensure proper drug accountability, including logging shipments, dispensing medication, and maintaining accurate records.
- Identify and address protocol deviations or unanticipated events.
- Participate in quality assurance audits and maintain accurate master logs for each study.
- Oversee investigational product (IP) management, ensuring proper storage, labeling, and restricted access.
- Maintain training and delegation logs, as well as safety reports, ensuring compliance with review and signature requirements.
- Uphold confidentiality of patient health information and sponsor data.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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