Under the direction of the Clinical Research Manager, the Coordinator organizes research information for various clinical projects and trials. The Coordinator selects and observes subjects and assists with data analysis and reporting. This position is also responsible for coordinating experiment scheduling and the collection of data.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Ensures all clinical activities are carried out in accordance with established research protocols and standards and in compliance with all applicable laws, regulations, policies and procedural requirements.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study
- Collaborates with the PI and institution to respond to any audit and implement approved recommendations
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participants’ eligibility or exclusion
- Under indirect supervision, plans, develops, and oversees day to day clinical activities and procedures, ensuring workflow and adequate care and treatment of research subjects.
- Direct nursing evaluation and/or other related care and consultation to patients as required.
- Oversees and coordinates the recruitment, care, and treatment of patient research subjects; coordinates services with other internal departments and allied service agencies.
- Coordinates, plans, and implements clinical pharmaceutical protocol for the study; monitors study activity and prepares reports to funding agencies and investigators as appropriate.
- Acts as liaison between investigators, ancillary departments, physicians, research subjects, sponsoring organizations, and/or regulating bodies while ensuring HIPAA regulations are followed.
- Accurately document information in medical record.
- Review biopsy/lab/radiology results and take appropriate actions regarding results.
- Educate patients regarding conditions, procedures, preps and medications.
- Schedule labs, radiology exams and other testing as ordered by MD and/or dictated.
- Other duties as assigned.
EDUCATION & EXPERIENCE: Bachelor’s degree in a scientific, health related, or business administration program, preferred. At minimum, must have a Bachelor’s degree. Must have at least two years of experience in a clinical research environment. Three or more years as a clinical research professional. Certification as a CCRC is preferred.
Job Type: Full-time
Pay: $26.00 - $30.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Medical specialties:
Schedule:
Education:
Experience:
- Clinical research: 1 year (Required)
- NASH, Crohn's and Ulcerative Colitis: 1 year (Required)
License/Certification:
Work Location: In person