Clinical Research Coordinator

Job Description:

• Perform daily functions required for multiple clinical trials.
• Adhere to GCP, ICH, and other relevant compliant requirements in tandem with the study protocol and KUR SOPs.
• Assist with completion of feasibility questionnaires.
• Responsible for participant recruitment and maintaining records of recruitment efforts and screening.
• Assist with informed consent under the guidance of the PI.
• Ensure subjects meet all inclusion/exclusion criteria and have been properly consented prior to screening and enrollment into any clinical trial. Ensure that the most recent IRB approved consent is being utilized.
• Coordinate participant visits from screening to follow up.
• Assist with the creation of source document templates, as needed, for clinical trials and manage subject study data.
• Complete training as required, both for KUR Research and project specific requirements.
• Perform basic lab procedures such as collecting, preparing, and shipping specimens.
• Maintain records of the proper receipt, storage, distribution and any shipments or transfer of study related materials (e.g. investigational product, lab specimens).
• Facilitate and attend sponsor visits (e.g. SIVs, PSVs, COVs, and audits).
• Prepare for and participate in regular team calls to review the status of current projects, identify site specific needs, and offer remote support when available.
• Ensure destruction/return of study supplies/equipment/investigational product prior to/on close out visits as directed by sponsor.

General CRC expectations:

• Maintain site temperature logs/calibrations and correct any study alarms from refrigerator or freezer Report any concerns to line manager.
• Reply to requests for information promptly, from internal and external queries.
• Foster a collaborative work relationship with KUR Research colleagues (e.g. Regulatory, QA, Legal, Operations, Finance, BD, etc.).
• Complete required training (e.g. GCP, COI, IATA, ICH, SOPs) within 2 weeks of hire and within a 30-day timeframe for annual renewals.
• Maintain 3rd party relationships per sponsor requirements, i.e., dry ice vendors, courier services, etc.
• Maintain site supplies, including but not limited to, general site supplies, sponsor specific, and participant paycards.
• Ensure office and workspace is organized and kept in an orderly manner.
• Other duties as assigned.

Technical Skills:

• Experience with clinical trial related data capture software (e.g., electronic data capture and clinical trial management systems).
• Experience working with the Microsoft Office suite of products.

Preferred Skills:

• Two years of research experience in a clinical research setting, Phases I-IV.
• Excellent attention to detail and a high level of organizational skills, including time management.
• Ability to succeed in a hybrid environment that includes independent task delivery and team collaboration.
• Working knowledge of HIPAA, federal, and state laws relating to privacy and consent.
• Knowledge of clinical trial terminology and use of forms such as 1572, ICFs and SAE reporting.
• Effective written and verbal communication skills.
• Able to apply effective problem-solving skills and rational judgment to a variety of situations.
• Organize tasks, set priorities, meet deadlines, and manage multiple tasks.

Education Requirements:

• Bachelor’s degree in a clinical or scientific field; or equivalent experience
• Experience working as a CRC or CRA in the clinical research setting.
• CRC certification preferred.