Clinical Research Coordinator II

About the role

The Clinical Research Coordinator II supports the execution of clinical trial activities, adhering to all applicable regulations. This role is part of the Kelly FSP division, a managed solution provider under Kelly Services, Inc.

Responsibilities

• Develop strong working relationships and maintain effective communication with study team members.
• Serve as a point of contact for the clinic and 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.
• 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.
• Carefully coordinate protocol-related research procedures, study visits, and follow-ups.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.
• Document 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 Clinic and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents data according to ALCOA.
• Perform other duties as required and/or assigned.

Requirements

• Knowledge of clinical trial terminology and practices.
• Prior GCP training and ability to explain the importance of GCP guidelines.
• 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 timeframes through effective prioritization of duties and functions in a fast-paced environment.
• Self-motivated and able 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.
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint).
• Education and Experience:
• 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.