Clinical Research Coordinator II

ESSENTIAL DUTIES

• 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.
• Care for protocol-related research procedures, study visits, and follow-ups.
• Aid in 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 documents data according to ALCOA.
• Perform other duties as required and/or assigned.

QUALIFICATIONS

• 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 timeframes 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.