Clinical Research Coordinator - Contract - Midlothian, VA
Make your mark in global health by assisting with high-impact clinical research with a leading CRO.
探花合集 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 standard operating procedures (SOPs).
Skills & Requirements:
- Experience in clinical research, with a strong understanding of regulatory and protocol compliance.
- Proficiency in phlebotomy and handling laboratory specimens.
- Strong organizational skills and attention to detail for data entry and documentation.
- Ability to manage multiple tasks and problem-solve effectively.
- Excellent communication skills for interacting with patients, investigators, and study sponsors.
- Familiarity with electronic data capture (EDC) systems and good documentation practices.
The Clinical Research Coordinator's responsibilities will be:
- Manage the enrollment process for clinical trials, aiming to exceed recruitment goals.
- Collaborate with recruitment teams and site management to optimize recruitment strategies.
- Educate patients or caregivers about study details and associated procedures.
- Monitor study activities to ensure compliance with protocols and regulatory requirements.
- Maintain and self-audit study e-regulatory binders, ensuring all documentation is up-to-date.
- Schedule study visits and monitoring activities as per protocol and study plans.
- Complete source documentation during patient visits, ensuring accuracy and adherence to good documentation practices.
- Enter collected data into electronic data capture (EDC) systems within one business day and resolve queries within 48 hours.
- Manage inventory of lab and study supplies to meet study needs and enrollment goals.
- Attend investigator meetings and site initiation visits, gathering and sharing relevant study information.
- Maintain accurate records of study activities, including case report forms and drug dispensation logs.
- Perform protocol-specific procedures such as vital signs, electrocardiograms, and specimen collection.
- Communicate with laboratories and investigators regarding findings and adverse events.
- Oversee drug accountability, including logging shipments, dispensing medication, and maintaining compliance with study protocols.
- Maintain master logs for each study, including informed consent forms, patient IDs, and enrollment records.
- Participate in quality assurance audits and ensure investigational product (IP) management, including proper storage and restricted access.
- Maintain training and delegation logs, as well as safety reports, ensuring they are reviewed and signed by investigators.
- 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.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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