Clinical Research Study Coordinator, (North Kansas City, MO)

JOB SUMMARY

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 under the direct supervision of a Study Manager, will support other study team members in order to achieve study objectives and corporate goals, including:

• Develop strong working relationships and maintain effective communication with study team members.
• Become the point of contact for the clinic as well as the sponsor for clinic related activities.
• Manage multiple concurrent trials
• Completes all protocol related training
• Perform patient/research participant scheduling
• Collect patient/research participant history
• Collects and maintains source documentation
• Performs 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
• Assist in the informed consent process of research subjects.
• Support the safety of research subjects, report adverse events.
• Coordinate protocol related research procedures, study visits, and follow-up
• Assist with the screening, recruiting and enrollment of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities
• Collect, process and ship laboratory specimens
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines.

QUALIFICATION AND EDUCATION REQUIREMENTS

• Associates Degree or BS/BA in Life Science or related discipline
• Previous nursing experience in a clinical setting a plus
• At least one year of experience in coordinating clinical trials
• Prior training in GCP requirements
• Strong interpersonal skills with attention to detail a must.
• Demonstrated proficiency with word processing, spreadsheet, database, and
• presentation software (MS Office skills such as Outlook, Word, Excel,
• PowerPoint, SharePoint) and with clinical trial master filing systems.

WORKING CONDITIONS

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
Regular local and regional travel is required for this position.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.