QC & Data Management Specialist II

Flourish Research•Walnut Creek, CA

10d•$28 - $33•Onsite

About The Position

Flourish Research is a progressive and diversified clinical trial organization with capabilities in cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. They are committed to providing excellent care and fostering a diverse and inclusive work environment. Flourish Research is actively hiring a motivated and talented QC & Data Management Specialist II to join their team in Walnut Creek, CA. The company offers a comprehensive benefits package, a supportive work environment, and growth opportunities.

Requirements

Bachelor’s degree or commensurate experience.
Minimum of 2-3+ years’ relevant experience within the field of clinical or biological research.
Working knowledge of routine QC principles in a clinical research or closely related field.
Basic knowledge of Good Clinical Practice (GCP) standards and clinical research industry guidelines/regulations.
Demonstrates Flourish’s core values and all skill sets 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 strong written and verbal communication skills.
Must have good critical thinking, decision-making, 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.
Ability to quickly learn and adopt Flourish processes.
Ability to work extended hours as required.

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, investigators, and QC Manager, Team Leads, and/or 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.
Work closely with other staff members and sponsor representatives in a professional manner.
Assist with training and mentoring department new hires.
Assist with developing and implementing key initiatives in the department.
Assist with identifying, developing, and implementing process improvements.
Perform all duties in a timely and cost-effective manner.
Represent Flourish 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’s offices.
Additional duties as assigned by management.