JOB SUMMARY: clinical coordination of all aspects of adult and/or pediatric clinical research trials primarily sponsored by pharmaceutical companies.

Responsibilities include, but are not limited to, the following:

Clinical Support

• Performs all aspects of research related job duties in accordance with site-specific standard operating procedures
• Maintain required certifications such as IATA and GCP training
• Follow all federal, state, and local guidelines with regard to clinical trials
• Provides assistance to practice manager, clinical coordinator, mid-level providers, and physicians as related to drug study responsibilities
• Must efficiently manage own time, handle multiple demands and competing deadlines

Other

• Maintains patient confidentiality and complies with HIPAA and compliance guidelines established by the practice
• Maintains detailed knowledge of practice management and other computer software as it relates to job functions
• Attends CPR, OSHA, HIPPA, and OIG training programs if required by the practice
• Attends all regular meetings as appropriate

Supervisory Responsibilities

This job has no supervisory responsibilities.

Typical Physical Demands

Position requires full range of body motion including manual and finger dexterity and eye-hand coordination. Involves standing and walking. Employee will occasionally be asked to lift and carry items weighing up to 30 pounds. Normal visual acuity and hearing are required. Employee may work under stressful conditions. Employee may work irregular hours and be exposed to bodily fluids on a regular basis.

Typical Working Condition

Employee will have frequent exposure to communicable diseases, toxic substances, needle sticks and other conditions common to a clinic environment.

EDUCATIONAL REQUIREMENTS:

• High school degree required
• RN License/LPN License/CMA certificate desirable but not required
• CCRC Certificate Preferred

QUALIFICATIONS AND EXPERIENCE:

• At least two years experience in a clinical research setting preferred
• Knowledge and ability to perform venipuncture, subcutaneous injections, and intravenous medication preparation/administration
• Ability to procure basic vital signs
• Proven efficiency using electronic medical records and ability to perform database searches
• Familiarity with AthenaFlow EMR, spirometry, FeNo, and ECG preferred
• Knowledge and ability to utilize unique computerized data entry platforms for required study protocols
• Proven ability to recruit study subjects from practice’s patient database
• Familiarity with processing and shipping lab specimens, IATA certification preferred
• Ability to effectively interface with site’s regulatory personnel to ensure all regulatory requirements are fulfilled
• Ability to complete subject source documents in a timely manner for PI review prior to monitoring visits
• Familiarity with disease states for vast majority of our clinical trials (asthma, allergic rhinitis, chronic urticaria, atopic dermatitis) preferred
• Flexibility in scheduling in order to accommodate protocol requirements and/or subject needs, and attend investigator meetings
• Excellent communication and organizational skills
• Neat and professional appearance