QC & DATA MANAGEMENT SPECIALIST

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

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 offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

About the Job:

We are actively hiring a QC & Data Management Specialist to support our Walnut Creek, California Site.

Shift: Monday-Friday day shift (40 hours per week) Location: Walnut Creek, California FLSA Classification: Non-Exempt Compensation: $26 to $28per hour (depending on experience)

Requirements

Job Title: QC & Data Management Specialist

Department: Clinical FLSA Classification: Non-Exempt

PURPOSE: Provide quality control and data entry for charts that are entered into the QC data entry process. Work with clinical research coordinators to ensure Flourish site standards are utilized, and data entry is provided to the sponsors in an accurate and timely manner.

JOB RELATIONSHIPS:

Reports to: Site Director

Departments Supervised: N/A

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 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 time- and cost-effective manner.

Represent Flourish Research 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.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

Work is normally performed in a typical interior/office work environment.

Local travel required.

Monitor/Sponsor Customer Service.

Daily computer use.

Occasional night and weekend work schedules.

Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

Ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

Education: Bachelor’s degree or commensurate experience.

Experience: Minimum of 1-3+ years’ experience within the field of clinical or biological

research.

Knowledge and Skills:

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 in a team, and have 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, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

EEO STATEMENT FOR ALL POSTINGS (Place under Benefits Summary, above)

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.