We have an exciting opportunity to join our team as a Clinical Research Coordinator!
The Clinical Research Coordinator performs a variety of clinical study activities to assist the Clinical Research Coordinators, Center Manager, and the Investigator(s) in the conduct of a clinical study. A Clinical Research Coordinator I is responsible for learning and performing with supervision all the basic activities to conduct a clinical study. A Clinical Research Coordinator I can only manage studies under the supervision. of a Senior Clinical Research Coordinator or Center Manager.
Conduct clinical studies according to FDA regulation and guidelines.
Manage workflow to conduct the studies accurately and in compliance with ICH/GCP.
Protect the safety and welfare of the study subjects by ensuring that the study is conducted properly and in compliance with ICH/GCP and Optimal Research Standard Operating Procedures.
Knowledgeable of the Sponsor’s protocol so that all study activities are completed correctly.
Implement subject recruitment strategy in conjunction with the Senior CRC or Center Manager.
Recruit and screen the potential study subjects according to the protocol’s inclusion and exclusion criteria.
Ensure that IRB approval is obtained prior to study initiation and that the IRB requirements are met throughout the duration of the study.
Collect and submit all required regulatory documents at study start up in a timely, accurate, and complete manner.
Obtain proper informed consent, per Optimal Research SOP, from each study subject prior to participation in the study.
Schedule visits for each study subject, within visit window when possible. At each visit, perform defined activities completely and accurately.
Report all adverse experiences to the Investigator and Serious Adverse Events to the Principal Investigator, Center Manager, and Sponsor immediately.
Maintain adequate and accurate source documentation for each study subject that record all observations and data during the study.
Complete the Case Report Form/EDC for the study accurately, completely, and in a timely manner
Assign study subject numbers and maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies. Any discrepancies are to be noted and explained in a note to file.
Maintain all required documentation in the study, per Optimal Research SOP.
Knowledge and compliance with Optimal Research Standard Operating Procedures.
Communicate with the Sponsor Representative and Investigators regarding study activities as necessary.
Meet with the Sponsor representatives to discuss the conduct of the study and review study data.
Perform all other duties as assigned.
This position has openings in both our Rockville, MD and Austin, TX offices.
Education Experience / Certification
Requires a degree as a Medical Assistant, Emergency Medical Technician, Medical Laboratory Assistant or equivalent experience
At least one (1) years’ experience in a healthcare environment
6 months of clinical research experience
Good interpersonal, written, and verbal communications skills
When you are ready to join a company that is dedicated to quality and excellence in service, choose Optimal Research.Our employees have chosen Optimal Research because they know they can make a difference – not just in the successful execution of research programs but in our company’s success. We pride ourselves in providing high quality clinical research built on the skills and talent of our clin...ical research professionals. If you are a qualified individual who is seeking to make a difference, service-oriented, and committed to quality; we want to hear from you.Become part of a growing organization that is committed to career development and opportunity.Optimal Research is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding non-discrimination.