RESEARCH STUDY COORDINATOR

RESEARCH STUDY COORDINATOR:
The Clinical Research Coordinator manages the collection, documentation and maintenance of clinical data while ensuring compliance with protocol and overall clinical research objectives. Responsibilities include but not limited to:
― ♦ Complete source documentation for each prospective research participant.
― ♦ Responsible for gathering necessary information from the research participants (i.e. HIPAA, Medical Chart Release
Authorization, Questionnaires).
― ♦ Responsible for the Informed Consent Process.
― ♦ Responsible for maintaining data and information in the source documents.
― ♦ Responsible for reviewing inclusion and exclusion criteria for the PI.
― ♦ Responsible for ensuring all study specific procedures are followed in the order set forth by the study protocol.

ASSISTANT RESEARCH COORDINATOR

ASSISTANT RESEARCH COORDINATOR:
The Research Assistant will be responsible for coordination and marketing process between staff members; Site Manager, Study Coordinators, Regulatory Coordinator, Lab Technician, Investigators and Patients. Responsibilities include but not limited to:
― ♦ Responsible for all tasks assigned by staff members, Site Manager and Administration.
― ♦ Assist the Study Coordinator with patient’s visit.
― ♦ Assist with Scheduling the patient for their visits
― ♦ Assist the Lab Technician
― ♦ Assist with incoming and outgoing mail
― ♦ Assist with all deliveries to and from the Site

REGULATORY AFFAIRS COORDINATOR

REGULATORY AFFAIRS COORDINATOR:
The Regulatory Coordinator manages the collection, documentation and maintenance of clinical data while ensuring compliance with protocol and overall clinical research objectives. Responsibilities include but not limited to:
― ♦ Responsible for Initial Submission of new protocols to the Independent Review Boards (IRB).
― ♦ Responsibilities include but not limited to preparation of FDA Form 1572, Financial Disclosures, Curriculum Vitae(s) of investigators, Site Application to conduct study and all other Regulatory Documents necessary for initial submission.
― ♦ Primary IRB Contact for ongoing protocols as well as protocols for initial review, thereby assisting the ethical review boards with any questions or concerns they might have regarding these protocols.

RESEARCH LAB TECHNICIAN

RESEARCH LAB TECHNICIAN:
The Lab Technician will be responsible for the daily activities of the Lab. It is the Lab Technician’s responsibility to ensure all lab draws and or ECGs are appropriately collected, processed and dispatched from our facility on a daily basis. The Lab technician is an integral part of the team must be organized, collaborative and efficient, as well as adapt to the on-going daily requirements of the company. Responsibilities include but not limited to:
― ♦ Clinical laboratory technician will perform routine tasks in the laboratory; vitals, ECG, blood draw, Urine collection, etc.
― ♦ Maintain lab kit inventories at appropriate levels (keep these to a minimum due to storage availability)
― ♦ Order lab kits as needed (keep these to a minimum due to storage availability)
― ♦ Check for expired kits and discard expired kits (must generate a list of destroyed kits for Management and SC so a NTF may be generated for the ISF)
― ♦ Generate lab supply list for Management to order (needles, gauze, alcohol swabs etc)

MEDICAL OFFICE RECEPTIONIST

MEDICAL OFFICE RECEPTIONIST:

Serves patients by greeting and helping them; scheduling appointments; maintaining records and accounts.

MEDICAL OFFICE RECEPTIONIST SKILLS AND QUALIFICATIONS:
Multi-tasking, Flexibility, Telephone Skills, Customer Service, Time Management, Organization, Attention to Detail, Scheduling, Word Processing , Professionalism, Quality Focus