Clinical Research Assistant

Reports to: Site Director

Job Summary

The Clinical Research Assistant (CRA) is responsible for supporting the clinical research team and the implementation of the clinical trial program’s day-to-day operational activities. Job duties will be designated by members of the research team and will be supervised to ensure thorough, ethical, and compliant completion of tasks in accordance with research regulations, guidance, local laws, and policies. This role has an emphasis on data management but may also support additional research activities. 

Duties

• Prepares or creates source documents for study team, as requested 

• Prepares laboratory kits for study visits, ensuring accuracy through confirmation by the study coordinator or laboratory coordinator

• Monitors study supplies related to laboratory, rating scales, source documents, recruitment materials in common areas, etc.

• Supports and performs QC of all source documents, both paper and electronic, identifying discrepancies and collaborating with study staff to correct errors

• Supports resolving or escalating queries within the established timelines

• Prepares study binders for source document storage as instructed 

• Enters study participant data from source documents into client databases in accordance with the eCRF completion guidelines/data management plan and study timelines
• Performs adverse event and concomitant medication count (source vs. eCRF)
• Performs timely lab result tracking
• Responsible for the accurate and timely filing of all study-related documents, including study participant reports (i.e. labs, imaging, medical records, etc). 

• Ensures that study participant source document files/binders are ready for monitoring visits. May also assist with monitor visitors, including greeting upon arrival/registration and ensuring study files are returned to Records Room at the end of each day/visit

• Reports protocol deviations promptly to appropriate study team members

• Archives completed study documents according to established SOPs and work instructions

·      Supports the study team on external institutional activities like community outreach events, memory screening events, direct mailings, etc.

• May field study interest calls, fax referrals, and collect contact information after any advertising or outreach efforts that generates large volume of contacts to the site 

• May support the recruitment team in reviewing the site database for potential study participants or attend community memory screening events

• Schedule in-clinic or community-based memory screenings into working schedules

The duties above are representative of the nature and level of work assigned and may include other duties as assigned/delegated.

EDUCATION REQUIREMENT

• High School Diploma required / Associate's preferred.
• Bilingual English/Spanish preferred.

KNOWLEDGE, SKILLS, ABILITIES

• Proficiency in MS Office applications required.
• Excellent oral and written communication skills required.
• Excellent organizational skills required.
• Knowledge of medical terminology preferred
• Excellent attention to detail required.