As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Job Duties and Responsibilities:

• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters following local and federal guidelines.
• Assists with clinical trial budgets and patient research billing.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
• Performs phlebotomy services according to CSMC policies and procedures.
• Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated
• Identifies patients and patient specimens by strict adherence to established procedures; labels samples accurately and completely.
• Reports test results to appropriate individuals and exercises professional discretion with patient information.

Education:

• High School Diploma/G.E.D., required.
• Bachelor's degree in Science, Sociology, or related degree, preferred.

Licenses/Certifications:

• ACRP/SoCRA (or equivalent) certification is preferred.

Experience:

• Clinical Research experience is highly preferred.
• Understanding of general research objectives.

Physical Demands:

Standing, Walking, Sitting, Lifting 50 lbs., Carrying 50 lbs., Pushing 75 lbs., Pulling 75 lbs., Climbing (Rarely), Balancing (Rarely), Stooping (Rarely), Eye/Hand/Foot Coordination, Crouching (Rarely), Crawling (N/A), Reaching, Handling, Grasping, Feeling, Talking, Hearing, Repetitive Motions, Kneeling (Rarely)