Clinical Research / Regulatory Coordinator

Department:

SOM KC Psychiatry & Behavior Sciences

• ----

Administration

Position Title:

Clinical Research / Regulatory Coordinator

Job Family Group:

Professional Staff

Summary:

Work collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall coordination, management, and execution of clinical research studies. Manage clinical research studies by coordinating and participating in: 1. the collection, compilation, documentation, and communication of clinical research data; 2. the management of study specific Regulatory requirements throughout the study; 3. the monitoring of participants' progress including documenting and reporting adverse events and 4. the participation in periodic quality assurance audits of protocols.

Job Description:

Required Qualifications:

• Education: Associates degree plus two years required work experience OR an equivalent combination of relevant post-secondary education and work experience that equals 4 years. Experience may substitute for a degree on a year for year basis


• Knowledge of FDA regulations, ICH-GCP guidelines, and KUMC policies and procedures, Microsoft proficiency (Word, Excel, Power Point) computer spreadsheet skills.


• Skills: Excellent communication, writing, organization, presentation skills. Attention to detail, proficient with time management challenges, ability to effectively interact with multidisciplinary teams including physicians, administrative staff. Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.

Preferred Qualifications:

• Prior CRC/Regulatory experience.


• Experience in health behavioral education is desirable.

Job Duties Outlined:

• Prepare and/or submit the required study specific Regulatory documents per protocol, KUMC policy, and FDA standards. See listing of specific items such as startup documents, Trial Master File, required study specific IRB documents


• Assist principal investigator to identify and recruit subjects by educating potential patients and evaluating potential patients' eligibility for specific clinical trials.


• Management of biorepository.


• Create/Maintain source documents


• Enter protocol required data on source and complete paper/e case report forms (eCRFs) as required for clinical trials.


• Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors per protocol/CRO specifications. IRE, AEs of special interest.


• Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.


• Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy.


• Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.


• Prepare documentation and participate in study monitoring visits, reviews, and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.


• Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.


• Work closely with the Research Administration (Institute) and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.


• Attend continuing education, research and training seminars as requested by manager.


• Other relevant duties as requested by the supervisor.

Required Documents:

• Resume/CV


• Cover Letter

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Pay Range:

$49,000.00 - $74,000.00

Minimum

$49,000.00

Midpoint

$62,000.00

Maximum

$74,000.00