Clinical Research Coordinator

Job Description

Job Summary:

• The Research Assistant is responsible for supporting the lead coordinators in coordinating multiple complex trials through the protocol life cycles of activation, implementation and closure.

Duties and Responsibilities:

Research Study Execution:

• Collect study data through a variety of methods, per study protocol (e.g., administer surveys, observe/conduct study activities and record outcomes, electronic medical record data abstraction, biospecimens).
• Perform clinical tests and procedures in accordance with the study protocol, following adequate training.
• Record and organize study data and complete applicable case report forms (electronic or paper) as required in accordance with good clinical practice and ALCOA-C principles.
• Manage study visits as applicable (e.g., schedule/coordinate visits, prepare materials, manage research charges, etc.).

Research – Subjects/Ethics:

• Maintain administrative study documentation (e.g., delegation of authority logs, training records).
• Assist in the development and submission of regulatory applications and/or study materials (e.g., recruitment materials, informed consent forms).
• Gather and store required regulatory documentation.
• Prepare for study monitoring, participate in monitoring visits, and assist with corrections as applicable.
• Track and document protocol deviations and adverse events.

Participant Management:

• Screen and recruit study participants for studies per study protocol and applicable standard operating procedures.
• Obtain informed consent from study participants.

Research – Project Management:

• Participate in basic study start-up activities.
• Participate in site initiation visits, study start-up meetings, and closeout visits for research studies.

Research – Quality Control:

• Ensure accuracy of data collected by conducting quality assurance/quality control procedures.
• Report variations or discrepancies in data collected.
• Recognize discrepancies in patterns and make recommendations for process improvement.

Research – Lab Operations:

• Maintain study supplies (e.g., laboratory kits, administrative supplies).
• Track and ship biospecimens, as applicable.

Minimum Requirements:

• One year of experience of patient facing clinical research experience.

Preferred Qualifications:

• Experience in clinical research.
• EPIC medical records experience.
• SOM employees that work in a clinical environment must provide verification of vaccination using the COVID-19 Vaccine Certification Form or have received a medical or religious exemption through client Employee Occupational Health by Sept. 21 to maintain their clinical privileges.

Must Have:

• Preference will be given to an individual with excellent problem-solving skills, organizational skills, ability to exercise excellent judgment, work independently and make sound decisions in the absence of formal guidelines.
• This person should be resourceful.

Nice to Have:

• Prefer individual with working knowledge of EPIC.
• Working knowledge of and the ability to interpret and apply a wide variety of departmental, University, State, and Federal policies and procedures is preferred.