Senior Clinical Research Coordinator

2 days ago

Richmond, Virginia, United States Commonwealth of Virginia Full time
Job Title: Senior Clinical Research Coordinator

At the Commonwealth of Virginia, we are committed to advancing knowledge and innovation in the field of clinical research. We are seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our team.

Job Summary:

The Senior Clinical Research Coordinator will be responsible for facilitating multiple clinical research trials with a focus on substance use disorders. This role will involve participating in all aspects of the studies, contributing to data collection, processing, analysis, and dissemination, and supervising research assistants and student worker staff.

Key Responsibilities:
  • Maintain advanced understanding of clinical research management duties from study initiation to closeout.
  • Ensure compliance with IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
  • Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies.
  • Assist in the training of research assistants and student researchers on the team.
  • Serve as an ongoing resource for providing information and expert advice on clinical research issues.
  • Lead the development of best practice guidance and work aids for CRCs in areas such as study activation, study coordination, data management, and records management.
  • Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.
  • Establish standard operating procedures for all research-related activities.
  • Overall implementation and daily management of research protocols.
  • Clinical research activities including screening, enrolling, and testing participants, as authorized by the Principal Investigator.
  • Ensure IRB submissions are complete and submitted on time. Adhere to study timelines and deliverables.
  • Responsible for key aspects of the human resources process, annual reviews and on-boarding for postdoctoral fellows, research assistants, and interns, including close supervision and training of research assistants and interns.
  • Organize and set agendas for meetings and take meeting minutes.
Requirements:
  • Bachelor's degree or equivalent applicable combination of training, education and experience.
  • 3 years minimum direct experience managing study coordination and regulatory affairs for clinical trials.
  • Strong communications skills, attention to detail and time management skills.
  • Ability to set priorities, make timely decisions and meet deadlines while working on multiple projects.
  • Ability to work collaboratively and cooperatively in a large and complex organization and in a diverse and fast-paced work environment.
  • Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training.
  • Computer skills including word processing, data entry, spreadsheet, database management, and mid-level data analysis/statistical/programming skills required.
Preferred Qualifications:
  • Prior experience in administrative and financial management in an academic setting (including a working knowledge of state/university purchasing, travel, personnel administration policies and procedures).
  • Prior experience with grant submissions, research administration, pre/post award functions, subawards, working knowledge of NIH and other federal and state regulations/policies.
  • General understanding of IRB policies pertaining to regulatory requirements in human research.
  • Research experience with human subjects, including data collection, coding, and analysis.
  • Familiarity with open science platforms (e.g. OSF) and electronic data capture platforms (e.g. Qualtrics, REDCap, Inquisit/Millisecond).
  • Master's degree.
  • Certified CRC (CCRP, ACRP-CP, CCRC, or CCRA) certification.
  • Experience working with subjects with mental health disorders or substance use disorders.
  • Experience administering semi-structured interviews (ie ASI, SCID, or MINI).
What We Offer:

We offer a competitive salary and benefits package, including choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays, and more.

Explore our benefits further here: https://www.vcu.edu/hr/benefits

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