Quality Control Data Entry Specialist

The QC Data Entry Specialist ensures the accuracy and completeness of patient files by meticulously validating and entering data, utilizing the RealTime CTMS. This role requires a keen understanding of healthcare quality, regulatory standards, and medical terminology, although a clinical research background is not mandatory. This position will be in the Little Havana area and will be an onsite position.

Shift: Monday-Friday, 8 AM - 4:30 PM

Compensation: Competitive base compensation + comprehensive benefits, PTO, and 401k match

*paid overtime for weekend work, evening work, or early morning work as needed

RESPONSIBILITIES

Conduct a thorough and precise review of study charts utilizing SOPs, policies, GCP, GDP, and sponsor protocols. Indicate data points that are missing or discrepant and identify and report any trends to the QC Manager, Team Leads, and upper management.

Accurately enter data into an eCRF/CRF system according to the sponsor provided eCRF/CRF guidelines in a timely manner.

Identify and report missing data points or inconsistencies to the clinical research coordinator and QC Manager, Team Leads, and upper management as soon as possible.

Attend SIV meetings.

Report any discrepancies between the source and CRF/eCRF immediately to the CRC and the QC Manager, Team Leads, and upper management.

Resolve open queries thoroughly, accurately and in a timely manner.

Assist in sponsor monitor visits to resolve queries in a timely manner.

Possess the ability to work closely with other staff members and sponsor representatives in a professional manner.

Assist with training onboarding procedures.

Perform all duties in a timely and cost-effective manner.

Additional duties as assigned by management.

QUALIFICATIONS

Bachelor's degree or commensurate experience

At least 1 year of experience working in quality and/or data entry in healthcare. Clinical research experienced is not required, but nice to have

Familiar with working in a patient database, such as a CTMS

Understanding of ICH, FDA, and GCP regulations

Impeccable organizational skills and attention to detail

Excellent communication and interpersonal skills to effectively interact with the site team

An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven

High-level critical thinking skills

Working knowledge of medical terminology

Proficiency with computers and Microsoft Office Suite