Clinical Research Coordinator - Contract - Midlothian, VA
Make your mark in global health by assisting with high-impact clinical research with a leading CRO.
Proclinical 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.
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