BASIC JOB FUNCTIONS (SHORT SUMMARY OF THE PURPOSE OF THE JOB)

Provide quality assurance services for clinical databases and research records used in clinical trials. Ongoing review of data for accuracy, timeliness and completeness, prior to submission to monitoring agencies and sponsors. Interface with research teams to resolve data issues. Track and report defects and problems. Participate in other quality assurance activities.

ESSENTIAL FUNCTIONS: (JOB FUNCTIONS INTRINSIC TO THE POSITION AND MUST BE PERFORMED WITH OR WITHOUT REASONABLE ACCOMMODATION)

Must understand clinical data and clinical research protocols, and be able to recognize acceptable clinical values. Must be proficient in the use of clinical database systems. Must have strong communications skills and be able to work with others to resolve problems. Must be highly organized and able to work under tight deadlines and schedules.

PRIMARY DUTIES AND RESPONSIBILITIES (DUTIES AND RESPONSIBILITIES WHICH OCCUPY A MAJOR PORTION OF TIME AND IMPORTANCE IN THE JOB)

RESPONSIBILITY AND ACCOUNTABILITY SUMMARY

-Assist in ensuring the integrity of clinical trial data and database.

-Perform data review for acuracy, completeness and timeliness prior to submission to monitoring agencies and sponsor.

-Compare data with protocols schedule and identify errors, omissions, and/or discrepant elements; prepare reports.

-Notify research team members of data issues, errors, or potential deficiencies using established processes.

-Document data issues, responses/clarifications from research teams and assist in resolution.

-Document paper and electronic submissions to monitoring agencies and sponsors.

-Perform quality control of monitoring and protocol build, and other tasks as directed by management.

-Monitor discrepancies until resolution and ensure completeness of QC records.

-Analyze data discrepancies for trends and suggest solutions.

-Identify trends and sentinel events that are attributable to systems, personnel, and clinical issues for improvement and training purposes.

-Actively collaborate with management and team members to develop efficient QA/QC processes and systems.

-Ensure timely completion of all requested training courses, and prepare and submit timely and complete, scheduled and ad-hoc, reports

-Provide training/orientation to data managers and other personnel participating in data collection, abstraction/recording and submission processes.

-Develop and maintain good communications and working relationships with colleagues.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Bethesda, MD 20814