Clinical Research Coordinator – Wan Lab

Responsibilities

• Perform all duties within the Health Insurance Portability and Accountability Act (HIPAA) regulations;
• Cook with PI and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures, and ensure that all key personnel or persons engaged in the project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures, and provide additional training as needed;
• Aid in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of study visits, execution of research plan, and maintenance of documentation of training;
• Coordinate and facilitate monitoring and auditing visits, and respond to any audit findings and implement approved recommendations;
• Ensure protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures;
• Perform recruitment, consenting, screening, and enrollment of personnel, collect samples if immediately provided, develop promotional materials for study recruitment, and complete timely and accurate documentation of patient visits;
• Maintain inventory of study supplies, and ensure that stock levels are adequate and orders are placed on time;
• Prepare, update, and manage Institutional Review Board (IRB) documents, and create and maintain study protocols and update as needed;
• Enter survey data into REDCap (Research Electronic Data Capture), and train and oversee a chart review team (e.g., coordinate distribution of charts to a chart review team each week and obtain regular updates, validate clinical charts, train new clinical team members, and ensure that all charts are done uniformly);
• Cook with financial personnel for reimbursements and ensure timely reimbursements;
• Prepare informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs;
• Establish and organize study files, including regulatory binders, study specific source documentation and other materials, and retain and maintain all study records;
• Cook with information process with honest brokers to ensure that data remains de-identified for human subjects’ protection.

Qualifications

• A bachelor's degree in Nursing, health administration or equivalent combination of education and experience;
• Two years in clinical trials, research, or grants administration is required.

Preferred Qualifications

• Bachelor’s degree in nursing, public health, biological sciences, or related;
• Two years of experience at a healthcare facility in a clinical research coordinator role (essential) or equivalent;
• Working knowledge of medical terminology, HIPAA regulations, IRB regulations and submissions, Good Clinical Practice (GCP), electronic medical records, International Classification of Diseases (ICD), and Current Procedural Terminology (CPT) coding (highly advantageous);
• Innovative thinker with strong conceptual and problem-solving skills;
• Meticulous attention to detail with the ability to multi-task;
• Strong organizational, administrative, and planning skills;
• Ability to work under pressure and react effectively to emergency situations;
• Ability to work independently and as part of a team;
• Excellent documentation, communication, and computer skills (e.g., MS Office applications including Word, Excel, and PowerPoint);
• Passionate about clinical excellence.

Benefits

• This position is eligible for University benefits.

Pay

Salary Range: $59,322.00 - $96,762.00 per year

Schedule

Shift: Typically Monday – Friday, 8am-5pm