Cardiovascular Clinical Translational Research Coordinator II - Hyrbid in Nashville TN

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** Organization:
** Cardiovascular Med CRE
*
* Job Summary:

** 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..
** Preferred Skills & Experience*
* * Clinical research experience in a patient-facing research setting, with preference given to candidates whose experience extends beyond laboratory-based research.
* Experience obtaining informed consent and educating patients regarding study participation.
* Familiarity with CITI training and clinical research compliance requirements.
* Experience with patient screening, eligibility assessments, and protocol implementation.
* Knowledge of regulatory processes, IRB requirements, and clinical research documentation.
* Experience collecting, managing, and maintaining accurate clinical research data.
* Proficiency with electronic data capture systems, research databases, and related technology platforms.
* Strong attention to detail with the ability to ensure data quality and regulatory compliance.
* Excellent communication and collaboration skills with the ability to work effectively with patients, families, investigators, and multidisciplinary teams.

KEY RESPONSIBILITIES
• 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 conductof 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, assuringparticipants 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 historicalinformation to ensure only appropriate subjects are enrolled in clinical/translational trials andremain 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 andgood clinical practice. Participates in site visits from sponsor, regulatory authorities and…