Description

The CRC is a specialized research professional who supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC is responsible for training on and carrying out the procedures required per the protocol. This involves a variety of complex activities involved in the collection, compilation, documentation, and data entry of clinical research data. The CRC is responsible for study recruitment and retention activities required to meet contracted study goals.

• Ensure subject safety across all trials. Adhere to PENTA Research SOP's and all federal requirements. Providing excellent customer service.
• Coordinate Phase I through Phase IV clinical pharmaceutical trials. Duties include obtaining suitable patients who meet all admission criteria, assisting with patient education, adhering to the study protocol and maintaining proper documentation according to the protocol and regulatory requirements. Ensure data is entered as per study requirements. Performing technical requirements of the protocol, including phlebotomy.
• Documenting laboratory data and adverse reactions, correcting discrepancies, anticipating possible problems and resolutions, maintain communication with the monitor from the sponsoring company.
• Develop and implement the recruiting plan for each enrolling study. Monitor subject accrual rates and implement action plans for accrual issues.
• Work off site as needed as a PENTA research coordinator.
• Manage annual reports to the IRB. Document protocol deviations and report to the IRB as required.
• Assist with the study feasibility process assessing the trial, communicating with the sponsor and PI, and attending Pre-Site Visits.
• Create and manage the recruitment research database.
• Manage special projects and other research initiatives as assigned.
• Maintain IATA and CITI certifications.

Requirements

Minimum Requirement

• Relevant degree (e.g., CMA, LPN, BS) or equivalent combination of experience and education (CCRC certification preferred)
• At least 1-2 years of experience in research or health care field

Key Competencies

• Knowledge of ICH GCP, CFR guidelines and industry requirements.
• Clinical knowledge to perform clinical duties. (Phlebotomy, ECG's, Spirometry)
• IATA certification-knowledge in specimen processing and shipment
• Oral/written communication skills
• Interpersonal skills
• Time Management/Work Prioritization
• Problem solving skills
• Computer skills
• Detail Oriented
• Customer Service Oriented