This Clinical Research Coordinator is a full-time staff position in Midwestern University’s department of Clinical Research Services (CRS). The general purpose of this position is to assist in execution of clinical research studies under direction of the Director of CRS. Although this position will be based at CRS Glendale Campus, this individual may be expected to travel and/or be located at clinical study sites in Arizona.
The Clinical Research Coordinator will assist in reviewing research protocols, coordinate patient recruitment, review and comply with standard operating procedures (SOPs), collect and manage research data, and initiate and manage an archive for research study reports. The Clinical Research Coordinator will work closely with study team members including Midwestern University or external investigators, study sponsor monitors, and will be training and mentoring Clinical Research Assistant(s) on clinical research studies or other activities as necessary. In addition, the Clinical Research Coordinator will be responsible for ordering and managing research supplies and complying with the expectations and SOPs of CRS and/or the study sponsors, learning and maintaining clinical trial management systems (CTMS), electronic data capture (EDC) systems, and implementation of quality control procedures for assigned clinical trials conducted by CRS.
Occassional travel out of state may also be required for training and CE events.
Essential Duties and Responsibilities
Execution of clinical trials to include (but not be limited to): anticipate clinical needs for multiple projects and perform chart preparation, review, and complete all forms and requisitions. Working with PIs to screen, qualify and enroll human volunteer subjects and/or privately owned companion animals into clinical research studies by taking medical histories, administering informed consent forms (ICFs), and obtaining all required signatures. Coordinate daily interactions with patients/subjects, physicians, and hospital personnel. Communicate with volunteer subjects to obtain detailed information on Adverse Events (AEs). Follow-up on volunteer subject complaints/questions. Manage compensation payment of subjects for participation in clinical trials. Ensure accuracy of research and/or subject billing. Manage collection and storage of biological specimens from research studies. Work with Data Management staff to develop source documents and case report forms (CRFs) for all clinical research studies.
Provide daily support for ongoing clinical protocols to complete clinical measurements and procedures which may include (but not be limited to): eliciting and verifying patient medical history, obtaining vital signs (height, weight, temperature, pulse, blood pressure), and preparation of laboratory samples for transport, storage, and/or analysis.
Serve as the liaison between CRS and the sponsor by working with the sponsor's clinical monitors/clinical research personnel ("Medical Monitors") to facilitate communications for all active protocols. Perform timely and accurate recording of patient/subject data into the medical record (source document) and transmission of data (case report forms, etc.) to the sponsor or sponsor's contract research organization (CRO). Work with PI/Medical Monitors to grade and classify adverse events, provide follow-up recommendations, and document resolution. Process and gather data concerning sponsor data queries and submit to appropriate agency for resolution. Track medication/device supply, compliance, and accountability. Randomize subjects per protocol and track medication/device supply, compliance, and accountability.
Ensure adherence to all documentation requirements and processes. Validate and train study team members on study related EDC systems. Attend and deliver protocol presentations at study Investigator meetings. Assist PIs and/or CRS faculty with study and/or site audits by government regulatory agencies or other external auditors.
Ensure compliance with policies and protocols of Midwestern University, Institutional Review Boards, FDA/governmental regulations, contract research organizations, and sponsors. Draft and submit written application forms to the CVM/CRS Clinical Research Committee or Midwestern University Institutional Review Board (IRB) for investigator initiated studies. Contact with representatives of such boards and organizations as necessary. Ensure patient/subject research confidentiality issues according to Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Assist and participate in case study reviews, abstract submissions, article reviews, and manuscript preparation with faculty and/or students.
Other duties as assigned by the Associate/Assistant Director/Director-CRS.
This position will not have any supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This individual must be able to work in a constant state of alertness and safe manner and have regular, predictable, in-person attendance. This person should enjoy working with college faculty, students, hospital staff, and the public. The individual should be able to handle complex scheduling issues. Collegiality and team work are essential attributes necessary to support a positive work environment.
Education and/or Experience
Bachelor’s degree from a four-year College or university is required. This individual must have 3-5 years of work experience related to clinical research. Previous experience in a hospital and/or health-system preferred. Current clinical research certification (i.e. SOCRA) desired. Bilingual or proficient in Spanish language is desired. Experience working in a team and customer service oriented environment. Excellent written and verbal communication skills. Phlebotomy certification or experience is also desired.
Computer proficiency in MS Office Suite (Word, Excel, PowerPoint, Access, Outlook). Previous experience with electronic data capture systems (e.g., Cerner, etc.) and electronic Case Report Forms (eCRFs) is highly desirable. Proficiency with, RedCap and ability to update a webpage is highly desirable.
High skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information to top management, and boards of directors.
High Skills: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Intermediate Skills: Ability to calculate figures and amounts such as discounts, interests, commissions and proportions, percentages, area, circumference and volume. Ability to apply concepts of algebra and geometry. The ability to compute rate, ratio, and percent and to develop and interpret data in tables and graphs is required. Knowledge of statistical analysis of clinical research data is highly desirable. Ability to manage budgets and compare agency and vendor pricing for obtaining contract services and purchasing, respectively.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is occasionally required to stand, walk, use hands to handle or feel and reach with hands and arms. The employee is regularly required to sit, talk and hear. The employee must occasionally lift and /or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.
Internal Number: CLINI02675
About Midwestern University
Midwestern University is an independent, not-for-profit corporation organized primarily to provide undergraduate, graduate, and postgraduate education in the health sciences. We are dedicated to the education and development of our students, faculty, and staff in an environment that encourages learning and personal development.