Clinical Research Coordinator II

Under general supervision, independently gathers research information for clinical projects. Manages clinical course of research participants according to research protocol. Selects and observes subjects and assists with data analysis. Utilizes discretion, creativity and latitude for decision making.

Essential Functions:

Meets with study participants. Follows study protocol performing duties/testing/data collection. Conducts study required tests and procedures. (Test may include: bone density scans, EKG's, balance testing, mental and physical assessments, blood draws, vitals, diary instruction and review, etc.)

Records data into patient research case report forms (CRF's) to include recording test results and reacting appropriately to abnormal results. Maintains accurate CRF's and source documents

Schedules appointments for various procedures inside and outside the department. Obtains medical records for any research hospitalizations and various other duties assigned.

Maintains study drug and supply inventory as well as study drug disbursement

Reports regulatory and Institutional Review Board issues appropriately (i.e. report adverse events and other regulatory data)

Qualifications:

Bachelor's Degree in related field of Science preferred

4-6 years clinical experience preferably in a research setting

Knowledge, Skills, and Abilities:

Excellent verbal and written communication skills required

Organizational and analytical skills required

Knowledge of FDA regulatory requirements is required

Knowledge of the principles of research design

Interpersonal/human relations skills

Attentiveness to detail

Ability to maintain confidentiality

Ability to operate personal computer and various software packages

Licenses/Certifications:

Basic Life Support (BLS) within 90 days of hire.