QC & Data Management Specialist II

About the role

FLOURISH RESEARCH is seeking a QC & Data Management Specialist II at our Walnut Creek, CA location. This position is non-exempt, works Monday to Friday, Day Shift, 40 hours per week, and offers a competitive compensation range of $28.00-$33.00 per hour.

Essential Job Functions

• 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.
• Afford assistance 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.

Requirements

• Bachelor's degree or commensurate experience.
• Minimum of 2-3+ years' relevant experience within the field of clinical or biological research.

Skills

• 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.
• 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.

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.

Flourish Research is an Equal Opportunity Employer

FLOURISH RESEARCH complies with the law regarding reasonable accommodation for handicapped and disabled employees.