Quality Assurance Data Entry Specialist
2 weeks ago
Flourish Research is seeking a highly motivated and detail-oriented Quality Control Data Entry Specialist to join our team. As a key member of our clinical trials team, you will be responsible for ensuring the accuracy and completeness of patient files by meticulously validating and entering data into our RealTime CTMS system.
Key Responsibilities:
- Represent Flourish Research in a professional and courteous manner when interacting with site staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician's offices.
- 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 experience 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.
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We strive toward excellence in clinical trials and healthcare, ensuring everyone deserves the best care, regardless of their background. We are committed to a safe work environment where all employees, customers, and patients are included and treated with dignity and respect. We celebrate diversity and promote education, acceptance, and inclusion. It is the policy of Flourish Research not to discriminate against any applicant for employment or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
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