Clinical Research Coordinator

2 months ago

Richmond, Virginia, United States Commonwealth of Virginia Full time
Job Summary

We are seeking a highly skilled Clinical Research Coordinator to join our team at the Commonwealth of Virginia. The successful candidate will be responsible for managing research studies in a compliant and efficient manner, ensuring all federal, state, university, and protocol requirements are followed.

Key Responsibilities
  • Under the direction of the Principal Investigator, conduct and oversee grants and coordinate research activities by preparing human assurance protocols, informed consent documents, and other research-related papers.
  • Oversee grant development by performing data collection and entry in compliance with HIPAA, GCP's, and sponsor required guidelines.
  • Participate in project planning and development of research protocols while ensuring adherence to accepted scientific research principles and compliance with relevant federal guidelines.
  • Conduct all assigned activities in compliance with national, local, and institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
  • Coordinate new study activation requirements, screens/enrolls participants, regulatory and compliance requirements, maintains appropriate study documentation/records, and manages study data.
  • Conduct clinical research activities as authorized by the Principal Investigator's documented Delegation of Authority and Training Logs.
  • Maintains current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
  • Understands, adheres to, and assists in developing/submitting IRB requirements, Human Subjects protection regulations, and all aspects of IRB-approved protocols.
  • Provides analytical writing and training support for projects.
  • Coordinates and researches scientific literature, evaluates, and summarizes findings, and assists PI in developing protocols based on findings.
  • Performs all other research duties as assigned.
Requirements
  • Demonstrated knowledge and understanding of clinical research management to include regulatory, human subjects' protection, study conduct, and data management requirements.
  • Extensive knowledge of ethical research issues and research protocols and guidelines also required.
  • Strong communication skills, both written and verbal, excellent interpersonal/organizational skills.
  • Strong interpersonal skills such as establishing rapport, maintaining participant motivation, empathic responding, ability to work effectively as part of a multidisciplinary team, and ability to use clinical judgment in (rare) emergency situations.
  • Working knowledge of Microsoft Office and SPSS or comparable statistical programs required.
  • Self-motivated, able to work independently, familiar with research regulations.
  • Able to work in an environment with a magnetic resonance imaging (MRI) scanner.
  • Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned.
  • Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
Preferred Qualifications
  • Bachelors of Science degree or equivalent in Psychology, Social Work, or related field.
  • Work experience in an academic medical center/university.
  • Familiarity with EPIC.
  • Phlebotomy Certification.
  • Experience conducting research in pediatric or adolescent populations.
  • Experience administering surveys in REDCap.
  • Experience in conducting mental health surveys with adults and youth.
  • Experience in mentoring and training student research trainees, incorporating them into research teams.

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