Clinical Research Coordinator I (102437)

U.S. Dermatology Partners•Lee's Summit, MO

1d•$55,000 - $65,000•Onsite

About The Position

Under the general supervision of a physician and the clinical and clinical research team in an outpatient setting, the Clinical Research Coordinator I (CRC I) is responsible for executing study-related activities from study startup through closeout. All tasks are conducted in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and USDP standards. The CRC I supports the Principal Investigator in the conduct of clinical trial visits, ensuring that participants are appropriately scheduled and that all protocol-specified procedures are completed accurately and in a timely manner.

Requirements

Meticulously detail oriented, professional attitude, reliable
Organizational skills to support accurate record-keeping
Ability to follow verbal & written instructions
Interpersonal skills to work as a team with patients and outside parties
Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
Mathematical and analytical ability for basic to intermediate problem solving
Basic to intermediate computer operation
Proficiency with Microsoft Excel, Word, and Outlook
Specialty knowledge of systems relating to job function
Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines

Nice To Haves

At least 1 year of research experience
At least 1 year of direct patient experience

Responsibilities

Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
Assist the PI, and team when applicable, the informed consent process with patients and their families
Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trials
Maintain all source documents and investigational drug accountability records
Enter source data into EDC efficient and accurately
Maintain regulatory documents related to ISF
Follow SOPs, policies, and procedures as set forth by the company
Review EDC for accuracy and completion, and resolve queries as they arise
Assists with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasks
Process prescriptions and prior authorizations as directed by physician.
Address patient and/or pharmacy questions concerning medication.
Enroll patients in patient education/assistance programs
Ensure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsors
Scans correspondence into EMR
Practices safety, environmental, and/or infection control methods
Assist clinical research manager in delegated tasks
Performs miscellaneous job-related duties as assigned
Process blood and urine samples in accordance with IATA and OSHA standards
Prepare necessary documentation for SIV, IMV, COVs and other sponsor related meetings
Working knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol