Job Overview

Will help manage the clinical aspects of adult and/or pediatric research trials. Most studies are industry-sponsored and focus on respiratory and allergy-related conditions.

Responsibilities and Duties

Clinical Support

• Perform all research tasks per site-specific SOPs, study protocols and assigned delegations
• Maintain required certifications (GCPs, IATA, medical license, etc.)
• Follow all applicable federal, state, and local clinical research regulations
• Assist PI, sub-investigators, and clinical staff as needed
• Manage time efficiently and meet deadlines across multiple studies

Compliance and Administration

• Ensure patient confidentiality and HIPAA compliance
• Completes all assigned AP training (such as CPR, OSHA, HIPAA, Compliance, Information Security, others) within designated timeframes
• Complies with Allergy Partners and respective hub/department policies and reports incidents of policy violations to a Supervisor/Manager/Director, Department of Compliance & Privacy or via the AP EthicsPoint hotline
• Models the AP Code of Conduct and demonstrates a commitment to the AP Compliance Program, standards and policies

Qualifications (Education and Experience)

• Minimum 1 year of experience as a clinical research assistant involving human subjects in a clinical/medical setting
• Efficient in using EMRs for data review and subject recruitment (AthenaFlow preferred)
• Comfortable developing and utilizing Excels spreadsheets
• Comfortable working with regulatory staff, clinical research coordinators and clinical research associates
• Timely documentation and source data completion for PI review
• Experience with electronic data capture (EDC) systems
• Familiar with use of handheld electronic subject diaries
• Experience processing/shipping lab specimens
• Knowledge of relevant conditions such as asthma, allergic rhinitis, chronic urticaria, and atopic dermatitis preferred
• Flexible schedule to meet protocol and subject needs
• Strong communication, organizational skills, and professional appearance

Typical Physical Demands

• Full range of body motion, including manual/finger dexterity and eye-hand coordination
• Prolonged sitting, occasional bending and lifting (up to 30 lbs)
• Normal vision and hearing necessary, correctable to normal range of record