Clinical Research Coordinator

Kelly Science and Clinical FSP is hiring a Clinical Research Coordinator for a renewable contract opportunity at our client site in Gilbert, Arizona!

The Clinical Research Coordinator I plays a key role in supporting the execution of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. The employee, working closely with study team members, will support other study team members in order to achieve study objectives and corporate goals.

• Develop strong working relationships, maintain effective communication with study team members.
• Serve as a point of contact for the clinic as well as the sponsor for clinic related activities.
• Support and work across multiple concurrent trials.
• Complete all protocol related training by due dates.
• Perform patient/research participant scheduling.
• Collect patient/research participant history.
• Collect and maintain source documentation.
• Perform data entry and query resolution.
• Support 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.).
• Adhere to an IRB approved protocol.
• Conduct the informed consent process of research subjects, once trained.
• Support the safety of research subjects, and report adverse events.
• Coordinate protocol-related research procedures, study visits, and follow-ups.
• Assist with the screening, recruiting, and enrollment of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities. Documentation of PSV and SIV activities.
• Collect, process, and ship laboratory specimens.
• Follow ethical and professional codes of conduct and escalate noncompliance as needed.
• Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified.
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and document data according to ALCOA.
• Perform other duties as required and/or assigned.

• Knowledge of clinical trial terminology and practices required.
• Prior GCP training and ability to explain the importance of GCP guidelines.
• Ability to identify and explain key protocol elements and perform study tasks.
• Demonstrated understanding of the basic participant safety requirements including safety reports, ICF elements, and role of the IRB.
• Excellent verbal and written communication skills, including the ability to convey ideas, information, and suggestions clearly and effectively.
• Excellent interpersonal and customer service skills.
• Strong organizational skills, including the ability to accomplish multiple tasks within the agreed-upon time frames through effective prioritization of duties and functions in a fast-paced environment.
• Self-motivated and ability to act and operate independently with minimal daily direction from manager to accomplish objectives.
• Strong analytical and problem-solving skills.
• High attention to detail and accuracy.
• Ability to maintain confidentiality with HIPAA guidelines, patient matters and other sensitive information.
• Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.

• Associate degree in life science or healthcare related field, bachelor’s degree preferred.
• Minimum 1 year of experience coordinating clinical trials.
• Previous nursing experience in a clinical setting a plus.
• 1-2 years of customer service experience.
• CCRC certification is a plus.

This job operates in a professional clinical research office environment. This role routinely uses standard office equipment such as…