Clinical Operations Lead

Overview
We are seeking a dynamic and experienced Clinical Operations Lead to oversee and coordinate the daily functions of our clinical research activities. This pivotal role involves managing clinical trial processes, ensuring compliance with regulatory standards, and leading a team of clinical professionals. The ideal candidate will bring a proactive approach to clinical operations, foster collaboration across departments, and uphold the highest standards of quality and integrity in research. Join us to drive innovative clinical development initiatives that make a meaningful impact on patient care and medical advancement.

***This is a contact position that could lead to a permanent position***

Responsibilities

• Active and unrestricted clinical license (e.g.LCSW, LPC, LPCC, Psychologist) in the state of practice.
• Minimum of 5-7 years of post-licensure clinical experience, with at least 5 years in a supervisory or leadership role.
• Lead and supervise clinical research teams, including coordinators, nurses, and laboratory staff, ensuring smooth operational workflows.
• Oversee the management of clinical trials from initiation through closeout, ensuring adherence to protocols, timelines, and regulatory requirements.
• Review and approve study documentation, including protocols, case report forms, informed consent forms, and monitoring reports for accuracy and compliance.
• Coordinate patient monitoring activities, including vital signs assessment, blood sampling, phlebotomy procedures, and adverse event reporting.
• Ensure data collection aligns with CDISC standards and is accurately entered into electronic data management systems while maintaining data integrity.
• Maintain compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other relevant regulatory frameworks governing clinical research.
• Facilitate training sessions on GCP principles, clinical laboratory procedures, EMR systems usage, and regulatory updates for staff members.Requirements
• Proven supervising experience within a clinical research or healthcare setting with a strong leadership record.
• Extensive knowledge of clinical trials management processes and regulatory compliance requirements such as FDA regulations and ICH GCP standards.
• Familiarity with medical terminology, clinical laboratory procedures, blood sampling techniques, and patient vital signs monitoring.
• Experience reviewing study documentation for accuracy and regulatory adherence; proficiency in data management software including statistical tools and EMR systems.
• Strong understanding of clinical development phases, research methodologies, and data collection protocols.
• Certification in GCP (Good Clinical Practice), preferably with an ICH GCP certificate from a recognized issuer for CA or equivalent jurisdiction.
• Ability to interpret complex data sets using analysis skills; experience working with CDISC standards is advantageous.
• Knowledge of HIPAA regulations to ensure patient privacy and confidentiality are maintained at all times.
• Excellent organizational skills with attention to detail in documentation review and compliance management; prior experience supervising teams is highly desirable. Join us as a Clinical Operations Lead to shape the future of healthcare innovation through meticulous oversight of our clinical research endeavors!

Pay: From $70,000.00 per year

Work Location: Hybrid remote in Virginia Beach, VA 23451