QC & Data Management Specialist

Flourish Research

3d•$27 - $30•Remote

About The Position

Flourish Research is seeking a remote QC & Data Management Specialist I to join their team. This role involves representing the site professionally, conducting thorough reviews of study charts, identifying and reporting data discrepancies, and accurately entering data into eCRF/CRF systems. The specialist will also attend SIV meetings, assist with sponsor visits, resolve queries, and collaborate with various stakeholders. The position requires a Bachelor's degree or equivalent experience, with a minimum of 1-3 years in clinical or biological research. Strong attention to detail, organizational skills, self-motivation, and the ability to work both independently and as part of a team are essential. Proficiency in Microsoft Office and internet-based applications, along with good written and verbal communication, critical thinking, and problem-solving skills, are also required. The ideal candidate will understand medical terminology and research concepts, and demonstrate knowledge of Flourish processes and clinical research industry guidelines.

Requirements

Bachelor’s degree or commensurate experience
Minimum of 1-3+ years’ experience within the field of clinical or biological research.
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 8 0 % of goals annually.

Responsibilities

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.