Clinical Research Coord Intermediate

Job Summary

The Mary H. Weiser Food Allergy Center is seeking a highly motivated clinical research Intermediate for multiple clinical research studies, ranging from moderate to complex, investigating the development of new treatment modalities for food allergies.

Responsibilities

• Functions as liaison between participants, investigators, sponsors and other interested parties such as members of Research Pharmacy and MCRU.
• Performing regulatory activities in collaboration with sponsors, local and central IRBs, the CTSU and associated entities.
• Recruiting potential study subjects, assisting in eligibility determination.
• Data entry related to participant screening & study visits.
• Maintaining accurate source documentation and essential documents.
• Tracking and maintaining data and sample collection and resolving data/sample queries.
• Collect and record participants' study-related data.
• Collect, process, label, store, and ship bio-specimens from participants for clinical studies.
• Work with lab staff to ensure biospecimens are handled appropriately and safely.
• Affordability of study budgets and financial reconciliation.

Required Qualifications

• Bachelor's degree.
• Minimum 3 years of directly related experience in clinical research and clinical trials.
• Certification is required through the Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professional (CCRP) or equivalent.
• Basic Life Support (BLS) certification.
• Exceptional organizational, interpersonal and communication skills (verbal and written).
• Ability to move equipment up to 25lbs.
• Comfort dealing with children and adults having a severe allergic reaction, or willingness to learn.
• Experience with data collection, data entry, and maintaining data confidentiality.
• Reliable transportation to travel to multiple work locations.

Desired Qualifications

• Working knowledge of Good Clinical Practice (GCP) and human subjects research procedures.
• Medical assistant or certified nursing assistant certification/licensure.
• Qualified/trained to perform venipuncture (blood draws).
• Ability to effectively communicate with staff and faculty of all levels.
• Experience working in a complex health care setting.
• Experience working with families, ideally with food allergies.
• Previous experience with EPIC and electronic data capture systems.
• Knowledge of university research policies and procedures.