Overview
The Department of Neurology is recruiting for a Clinical Research Coordinator III to support it's growing industry-sponsored clinical trial program. Neurology's clinical trial portfolio ranges from Phase I first in human trials to Phase III trials and encompasses several therapeutic areas including Parkinson's Disease, stroke, epilepsy, polyneuropathy conditions, Huntington's Disease, and registries for various therapeutic areas.
The Clinical Research Coordinator III performs a full range of clinical research duties at an advanced level and plans, organizes, leads, and performs comprehensive clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the program. The expectation is to perform with limited supervision and actively participate in decisions regarding the clinical research process, often leading teams. The impact of decisions of the Clinical Research Coordinator III are wide in scope affecting both internal and external partners. They cannot perform any tasks that by state or local law require a license to perform.
Responsibilities
Research Operations - Occasionally requiring tasks outside of defined operating hours:
Mentors, onboards, trains and oversees new clinical research coordinator staff on Good Clinical Practice (GCP), Human Subjects Protection (HSP) practices, the ethical conduct of research and a full range of clinical research duties including regulatory compliance.
May arrange/schedule required tests and other appointments.
Independently executes all aspects of the study operations (subject management/regulatory) with minimal oversight from the investigator or their designee.
Oversees subject management, such as data entry in Clinical Trials Management System (CTMS), scanning informed consents into Electronic Medical Records (EMR), and supporting data entry needs of the study.
May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision by investigator.
May interview study participants about their medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by principal investigator with collection of source data directly informed by medical records.
May communicate with participants throughout the course of the study.
May provide education and support to study participants and their families.
Prepares and submits regulatory documents to study sponsors and any applicable regulatory agencies.
May maintain study and regulatory documentation including working with the Institutional Review Board (IRB), ensuring all staff involved in the study are trained and that the training is appropriately documented.
Ethics & Participant Safety
Supports the evaluation of staff and assure compliance with GCP,HSP practices and the ethical conduct of research.
Assists and facilitates the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
Assists and facilitates with the development of documents related to safety and security.
Communicates to research participants the difference between clinical activities and research activities and the risks and benefits of study participation.
Data and Informatics
Trains others on the proper utilization of Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations.
Scores tests, enters data and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol.
Develops and implements data collection documents and instruments.
Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
Designs, develops or assists with development of Standard Operating Procedures (SOPs) for data quality assurance.
Adheres to processes and runs queries, summaries and reports to monitor the quality of data.
Monitors for and detects issues related to data capture, collection or management and suggests solutions.
Recognizes trends related to data quality and escalates as appropriate.
Uses required processes, policies and systems to ensure data security.
Leadership and Professionalism
Understands and employs the professional guidelines and code of ethics related to the conduct of clinical research and D-H and project specific training requirements.
Travels to investigator meetings and study training sites.
Provides guidance, oversight and mentoring to team members in skills and in performance expectations of service excellence, teamwork, communication, dependability and professionalism.
Site and Study Management
Independently organizes and manages clinical trials and research studies.
Conducts protocol reviews to assess the feasibility of potential studies.
Participates in study site selection activities.
Designs, develops and recommends recruitment and screening procedures and documentation.
Composes informed consent forms and protocol abstracts.
May participate in manuscript/abstract development.
Maintains other study documents and study management tools.
Provides expertise and guidance to the research team and investigators.
Participates in the preparation of grants or study budgets for funding department research.
Communication and Team Science
Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
Supports and provides guidance to other members of the research team.
Portfolio and Program Development & Management
Qualifications
- Bachelors or equivalent years of experience
- Masters in relevant field preferred
- 4 years of relevant research experience
- Ability to travel as required
Required Licensure/Certifications
- BLS required within 30 days of hire date
- Certified Clinical Research Coordinator (CCRC-ACRP) or Certified Clinical Research Associate (CCRA) or Certified Clinicial Research Professional (CCRP-SCRA)
- Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.
