DESCRIPTION

Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings. Provide direct assistance to the PI or Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing. Some laboratory bench work may be required as it relates to processing and analyzing patient samples.

MINIMUM QUALIFICATIONS

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's Degree; or an equivalent combination of education and experience.

• Proven experience performing clinical research duties in a clinical research environment. Experience working with FDA policies regulating clinical trials.

• Demonstrated experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Proven experience interpreting medical charts, experience in abstracting data from medical records. Experience completing clinical trials case report forms via hard copy and online.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Demonstrated experience with clinical trials participant or study subject recruitment.Experience coordinating study startup activities.

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Thorough knowledge of x-rays, scans, and other diagnostic procedures. Experience maintaining files and keeping records.

• Strong planning and organizational skills. Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• Excellent interpersonal, written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

PREFERRED QUALIFICATIONS

• Certification as a Clinical Research Associate or Coordinator.
• Experience working with research bulk accounts.
• Experience with investigational drug authorization criteria.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check and pre-employment physical.
• Occasional evenings and weekends may be required.