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Overview:

This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The employee, working closely with study team members, will achieve study objectives and corporate goals. 

Essential Functions

• Ability to coordinate as primary CRC on at least 1-3 studies of low to medium complexity, with oversight by a manager or higher-level CRC. 

• May assist as back-up CRC on other studies

• Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved

• Obtains informed consent of research subjects

• Develops strong working relationships and maintain effective communication with study team members

• Completes all protocol related training

• Performs patient/research participant scheduling

• Collects patient/research participant history 

• Collects and maintains source documentation

• Manages inventory and administers test articles/investigational product to participants 

• Performs data entry and query resolution

• Supports the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging, and laboratory handling manuals, etc.)

• Adheres to an IRB approved protocol

• Supports the safety of research subjects, report adverse events

• Coordinates protocol related research procedures, study visits, and follow-up 

• Facilitates pre-study, site qualification, study initiation, monitoring visits, and study close out activities

• Collects, processes and ships laboratory specimens

• May be asked to perform special project responsibilities and travel to other clinic locations, within the area, when needs arise

• Complies with Avacare and Sponsor policies, standard operating procedures (SOPs) and guidelines

• Performs other duties as assigned

Qualifications

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

• Clinical Research Coordinator experience within a similar setting preferred

• Clinical skills experience including obtaining vitals, phlebotomy, EKG, etc.

• Knowledge and experience of site operations and the drug development process

• Effective communication

• Computer proficiency in use of Microsoft Word, Excel