Clinical Research Coordinator

This position requires the Clinical Research Coordinator to be local to the Philadelphia area since this position will require the CRC to be going to our 5 office locations all in Suburban Philadelphia.

Job Summary

We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to oversee and facilitate clinical trials in our Pulmonary Office. The ideal candidate will possess a strong foundation in clinical research processes, excellent organizational skills, and a commitment to maintaining compliance with regulatory standards. As a Clinical Research Coordinator, you will be responsible for coordinating all aspects of clinical studies, ensuring data integrity, and supporting the advancement of medical knowledge through meticulous trial management.

Responsibilities

• Coordinate and manage clinical trial activities in accordance with protocol requirements, FDA regulations, ICH ,GCP, IRB, guidelines, and regulatory requirements.
• Review and verify study documentation, including consent forms, case report forms, and regulatory submissions to ensure accuracy and completeness.
• Monitor patient progress throughout the trial, including vital signs, blood sampling, and adverse event reporting while maintaining patient safety and confidentiality.
• Facilitate patient recruitment, screening, enrollment, and retention to meet study timelines.
• Manage data collection, entry, and management using electronic medical record (EMR) systems and adhere to CDISC standards for data consistency.
• Schedule and conduct study visits.
• Ensure compliance with HIPAA regulations and maintain meticulous documentation for audits and regulatory reviews.
• Utilize statistical software for data analysis when necessary to support research findings.
• Communicate effectively with sponsors, monitors, and investigators.

Qualifications

• Proven experience supervising clinical trials or managing clinical research projects within a healthcare setting.
• Strong knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques such as phlebotomy.
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance, and clinical development processes.
• Experience working with EMR systems and data management tools aligned with clinical research standards like CDISC.
• Background in nursing or related healthcare fields with clinical laboratory experience is highly desirable.
• Collect, process, and ship laboratory specimens as required.
• Bachelor's degree in Life Sciences, Nursing , or related field
• Strong organizational and multitasking skills
• Excellent communication and interpersonal abilities
• Certification (CCRC, CCRP) is a plus

Benefits:

• 401(k)
• Paid time off

Application Question(s):

• Advocare, LLC requires all employees to have a background check and a drug screening. Are you willing to have these done?

Education:

• Bachelor's (Required)

Experience:

• Clinical Trial Office : 1 year (Required)

Language:

• English (Required)

Work Location: In person