Remote QC & Data Quality Lead

Flourish Research; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Generous PTO

Job summary

Flourish Research is seeking a QC & Data Management Lead to ensure quality data collection per SOPs, GCP, and FDA guidelines. This remote role supports CRCs and CRAs, and oversees the QC Data Entry department.

The candidate will enter data into eCRF/CRF systems, identify data gaps, and assist in sponsor visits. Requires a Bachelor's degree and 4+ years in clinical research, with leadership experience.

Qualifications

• Bachelor's degree or commensurate experience.
• Minimum of 2 years in the department plus 2 years in related role within the clinical research industry.
• Industry certification, as applicable.

Responsibilities

• Review study charts against SOPs and sponsor protocols.
• Enter data into eCRF/CRF accurately and timely.
• Identify missing data or inconsistencies and report to CRC.
• Coordinate source document creation/approval.
• Report discrepancies between source and CRF/eCRF promptly.
• Notify leadership of major discrepancies.
• Resolve QC data issues thoroughly and timely.
• Assist sponsor monitor visits to resolve queries.
• Oversee QC Data Entry tasks to ensure timeliness and accuracy.
• Mentor and train team members in QC/DE processes.
• Attend PSVs and SIVs as needed.
• Conduct regular team meetings and 1:1s.
• Represent Flourish Research professionally in all interactions.

Skills

Quality control

Data management

GCP knowledge

FDA guidelines

eCRF/CRF systems

SOP adherence

Team leadership

Training & mentoring

Education

Bachelor's degree or equivalent

Tools

MS Office

eCRF/CRF software

Job description

Flourish Research is seeking a QC & Data Management Lead to ensure quality data collection per SOPs, GCP, and FDA guidelines. This remote role supports CRCs and CRAs, and oversees the QC Data Entry department.

The candidate will enter data into eCRF/CRF systems, identify data gaps, and assist in sponsor visits. Requires a Bachelor's degree and 4+ years in clinical research, with leadership experience.