Registered Nurse - Research - Community Health Systems : Job Details

Job DescriptionJob Summary The Registered Nurse, Clinical Research coordinates and manages the compliant execution of clinical research studies, ensuring adherence to protocols, regulatory requirements, and ethical standards. This role involves collaborating with investigators, research teams, and participants to ensure the successful implementation of studies. Responsibilities include protocol adherence, subject recruitment, regulatory compliance, data collection, and participant care within the scope of nursing practice. Essential Functions

• Coordinates the implementation and conduct of clinical research protocols, ensuring compliance with protocol requirements, regulatory standards, and timelines.
• Performs clinical assessments, treatments, and procedures within the Registered Nurse scope of practice as required by research protocols, including administration of medications, patient monitoring, and follow-up care.
• Manages subject recruitment, screening, informed consent, and enrollment, ensuring eligibility criteria are met and participants are informed of study details.
• Oversees study documentation, including regulatory submissions, case report forms, and data collection, ensuring accuracy and adherence to Good Clinical Practice (GCP) and FDA guidelines.
• Acts as a liaison between investigators, research staff, sponsors, and regulatory agencies, addressing protocol-related questions and ensuring effective communication.
• Conducts quality assurance reviews of study documents and regulatory submissions, identifying areas for improvement and ensuring data integrity.
• Maintains essential regulatory and study documentation, including training records, licenses, site certifications, and patient files, to support audits and inspections.
• Provides education and training to research staff and participants regarding protocol requirements, study expectations, and safety monitoring.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Associate Degree in Nursing required
• Bachelor's Degree in Nursing preferred
• 3-5 years of clinical nursing experience required
• 2-4 years of clinical research experience preferred

Knowledge, Skills and Abilities

• Strong understanding of clinical research protocols, regulations, and ethical guidelines, including FDA and NIH requirements.
• Proficiency in managing study documentation, regulatory submissions, and data collection.
• Clinical expertise in assessments, treatments, and nursing care within research settings.
• Effective communication and interpersonal skills for collaboration with multidisciplinary teams, sponsors, and participants.
• Attention to detail and organizational skills to manage multiple studies and regulatory requirements.
• Ability to analyze and solve complex problems in a dynamic research environment.
• Knowledge of electronic data management systems and medical record systems preferred.
• Bilingual (Spanish) is beneficial.

Licenses and Certifications

• RN - Registered Nurse - State Licensure and/or Compact State Licensure required
• BCLS - Basic Life Support obtained within the first 12 months of employment required

INDCLINICTo Apply, please email [email protected]