QC & Data Management Specialist

Role Description

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We are actively hiring a remote QC & Data Management Specialist I.

• Represent site in a professional and courteous manner (verbal, written and in appearance) when interacting with site staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics/hospitals and physician 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 e CRF/CRF system according to the sponsor provided e CRF/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/e CRF 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 time- and cost-effective manner.
• Additional duties as assigned by management.

Qualifications

• Bachelor’s degree or commensurate experience.
• Minimum of 1-3+ years’ experience within the field of clinical or biological research.

Requirements

• Demonstrates core values & all skills set required.
• Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
• Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task.
• Must have good written and verbal skills.
• Must have good critical thinking and problem-solving skills.
• Must be professional and have a strong work ethic.
• Must have the ability to adapt and take on additional tasks as requested.
• Must have the ability to understand medical terminology and research concepts.
• Must have ability to identify appropriate subject care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs, and IRBs.
• Demonstrates some knowledge of Flourish processes.
• Demonstrates some knowledge of clinical research industry guidelines/regulations.
• Assists with key initiatives/process improvements in the department.
• Assists with training company new hires.
• Completes at least 80% of goals annually.

Benefits

• Health, dental, and vision insurance plans.
• 401(k) with a 100% employer match on the first 4% of employee contributions.
• Tuition reimbursement.
• Parental leave.
• Employee referral program.
• Employee assistance program.
• Life insurance.
• Disability insurance.
• A generous PTO plan covering vacation, sick, personal days and 8 paid holidays.