Clinical Research Coordinator
1 month ago
- Handles an increased volume of studies / patients on study
- Assigned studies of increased complexity
- Independently identifies issues and proactively troubleshoots with investigators, sponsors and internal partners to ensure they are addressed.
- Analyzes problems / issues of moderately complex scope and determines solutions
- Coordinates research studies, including proactive identification of participants and supporting the PI in determining patient eligibility with limited guidance.
- Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility.
- Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance.
- Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source.
- Manages patient registration, data and treatment assignment.
- Participates in quality control and quality assurance activities related to study workflows and documentation.
- Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection & shipping biospecimens.
- Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice.
- Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source).
- Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable.
- Prepare and submit site or study-specific regulatory documents.
- Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders.
- Ensure timely regulatory reporting and thorough documentation.
- Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed.
- Completes role-based training and occupational training as applicable, e.g. blood borne pathogens, infection control, hand hygiene, donning and doffing PPE.
- Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings).
- Completes protocol required training as needed.
- Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated.
- Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request.
- Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support.
- This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change.
Qualifications - Bachelors Degree or 2+ years of previous study coordination or clinical research coordination experience.
- Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
- Ability to effectively communicate to and interact with patients in a compassionate and kind manner.
- Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
- Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
- Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
- Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
- Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
- A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
- Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
- Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner.
- Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.
- High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual.
- Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc.
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