Clinical Translational Research Coordinator II - Onsite, Nashville TN

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- Clinical Trials 130

Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies, under occasional guidance.

• Experience coordinating clinical research studies or patient‑facing healthcare programs.
• Experience recruiting, screening, and consenting participants/patients.
• Strong patient interaction skills with the ability to build rapport and provide excellent participant support.
• Ability to work independently with minimal supervision; highly organized, self‑motivated, and capable of managing priorities autonomously.
• Experience collaborating directly with physicians and healthcare providers.
• Proven ability to manage multiple responsibilities while maintaining attention to detail and regulatory compliance.
• Strong communication and interpersonal skills.
• Oncology experience.

• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
• Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
• Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation.
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness.
• Attends to query resolution in a timely manner.
• Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
• Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures.
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
• With direction,…