Clinical Research Coordinator

Job Summary:

The Clinical Research Coordinator (CRC) is responsible for the facilitation and coordination of daily clinical trial activities at the office site. This role is accountable for ensuring all trial activities are compliant with relevant GCP, ICH, and other relevant compliance requirements. The CRC will lead participant recruitment and enrollment efforts, adhere to protocol task completion, and enter data collected into a cloud-based trial management system. Role related activities include subject scheduling, management of study drug, and supporting study monitor visits. The CRC is required to apply a high level of detail and organizational skills while fostering collaborative relationship with KUR and site colleagues.

Job Location: Centreville & Bessemer

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.

· Assis 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.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Location:

• Centreville, AL (Required)

Ability to Commute:

• Centreville, AL (Required)

Work Location: In person