Clinical Research Coordinator - Cardiovascular Medicine

Department:

SOM KC Division of Cardiovascular Diseases

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CCR

Position Title:

Clinical Research Coordinator - Cardiovascular Medicine

Job Family Group:

Professional Staff

Job Description Summary:

This position is responsible for working collaboratively with multidisciplinary teams research and hospital staff to recruit screen educate and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection compilation documentation and analysis of clinical research data. Monitor participants progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.

Job Description:

Key Roles and Responsibilities:

• Under the direction of the Principal Investigator recruit and educate potential patients and evaluate potential patient eligibility for clinical trials.

• Assesses feasibility of research protocol including appropriate patient population budget and specific needs for the study.

• Maintain source documents and submit case report forms (CRFs) as required for clinical trials. Completes and corrects case report forms ensuring accuracy of all records connected with each study with attention to medical events and concomitant medications as well as documentation for each study related event.

• Recognize and report adverse events/serious adverse events to the Principal Investigator FDA and sponsors.

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

• Maintains current KURI-required education i.e. Human Subjects Protection HIPAA Adheres to GCP guidelines.

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

• Monitors awarded grants and contracts for compliance with performance reporting and accounting requirements.

• 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 Research Operations 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 Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.

• Attends all staff meetings as well as meetings both onsite and off-site as required by study. Serves as mentor for new staff members.

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

Required Qualifications:

Education

• Bachelors degree in health care related or biological field. Experience may be substituted for education on a year for year basis.

Work Experience

• 2 years prior research or related experience.

• Basic understanding of regulations governing clinical research (CFR GCP HIPAA).

• Knowledgeable of study budgets contracts and grant applications.

Preferred Qualifications:

• Cardiovascular research experience highly preferred.

• 3 years or more research experience highly preferred.

• Experience using medical terminology.

• Willingness to seek research certifications to further skills in the position.

Skills:

• Excellent presentation organizational and communication skills.

• 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.

• Strong work ethic detail oriented self- motivated and possess good interpersonal skills.

This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice.

Required Documents:

• Resume/CV

• Cover Letter

Comprehensive Benefits Package: