Job Description

Job Summary:
We are seeking a highly motivated and experienced Lead Clinical Research Site coordinator to perform day-to-day activities on multiple clinical studies and manage a team of research staff in a Rheumatology clinic (private practice). The ideal candidate will have a strong background as a Clinical Research Coordinator and an excellent understanding of regulatory compliance. Leadership experience preferred.

Qualifications:

Education: Associate or bachelor’s degree is preferred. An advanced degree or certification is a plus.

Experience: Minimum of two years of experience as a Clinical Research Coordinator (including a demonstrated ability to manage multiple studies) with at least one year as a lead study coordinator or in a similar role (preferred).

Skills:

• Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), and ethics committee requirements.
• Meticulous attention to detail to ensure accuracy in data collection, maintaining data integrity and compliance with regulations.
• Proficiency in data management systems.
• Strong organizational and time-management skills with the ability to manage multiple tasks and priorities.
• Effective communication and interpersonal skills, with the ability to interact professionally with patients, research staff, sponsors, etc.
• Detail-oriented and proactive individual with strong leadership abilities.
• Ability to work independently and as part of a team in a fast-paced environment
• Proficiency in Spanish is a plus.

Key Responsibilities:

• Serve as the lead study coordinator. Lead and manage multiple clinical studies, overseeing the planning, coordination, and implementation of research protocols.
• Ensure that participants are fully informed about the study obtain their consent before participation and address any questions or concerns participants may have throughout the study.
• Prescreen and identify eligible study subjects. Oversee recruitment of study participants, ensuring that inclusion and exclusion criteria are met. Follow-up with participants as needed.
• Collect, record, and manage study data in accordance with protocol requirements. Ensure data integrity, accuracy, and confidentiality.
• Maintain detailed and accurate study documentation, including source documents, case report forms, and adverse event reports.
• Ensure that all research activities comply with federal, state, and institutional regulations. Maintain accurate and up-to-date documentation.
• Facilitate effective communication with trial participants, ensuring they are well informed and comfortable throughout the research process.
• Manage the execution of multiple clinical trials, ensuring that all activities are conducted in compliance with study protocols, regulatory requirements, and ethical standards
• Ensure adherence to regulatory guidelines and institutional policies. Maintain up-to-date knowledge of regulatory changes and ensure all required documentation is accurate and complete.
• Review new protocols, prepare feasibility reports, and attend site selection and site initiation visits.
• Ensure that studies are approved by the Institutional review boards (IRBs).
• Ensure compliance with FDA, IRB, and institutional requirements.
• Prepare and submit regulatory documents, including Institutional Review Board (IRB) submissions and updates. Maintain accurate and up-to-date regulatory files.
• Coordinate the administrative aspects of clinical trials, including scheduling, budgeting, agreements, and resource management. Implement processes to enhance operational efficiency.
• Prepare for and manage audits and inspections by regulatory bodies, ensuring that all aspects of the study are compliant with regulations.
• Communicate effectively with all team members and ensure timely resolution of any issues. Address any issues or deviations promptly and effectively.
• May be required to attend occasional off-site meetings and Investigator meetings.
• Identify opportunities to enhance and expand research capabilities.
• Other assigned responsibilities as needed.

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Compensation to correspond with degree and experience.
Must reside in the North Houston area.

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