QC & Data Management Specialist II

Flourish Research; Walnut Creek (CA); On-site; USD 39,000 - 45,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee referral program

Life insurance

Disability insurance

Paid holidays

Job summary

Flourish Research is seeking a QC & Data Management Specialist II in Walnut Creek, CA. The role focuses on thorough data review, compliant data entry into eCRF/CRF systems, and identifying data gaps per sponsor protocols.

Responsibilities include coordinating with CRCs, investigators, and QC leadership; assisting with training and process improvements; and supporting sponsor visits to resolve data queries in a timely manner.

Qualifications

• Bachelor’s degree or commensurate experience required.
• Minimum of 2–3+ years’ relevant experience in clinical/biological research.
• Working knowledge of QC principles in clinical research or related field.
• Proficiency with Microsoft Office applications (Outlook, Word, Excel).

Responsibilities

• Review study charts for accuracy per SOPs, GCP, GDP and sponsor protocols.
• Enter data into eCRF/CRF systems per sponsor guidelines.
• Identify and report missing data or discrepancies to QC Manager and team.
• Attend SIV meetings and support sponsor monitor visits.
• Assist with training and mentoring new hires and process improvements.

Skills

QC principles

GCP knowledge

Microsoft Office

Detail oriented

Communication skills

Independent worker

Medical terminology

Process adoption

Education

Bachelor’s degree or commensurate experience

Tools

eCRF/CRF entry tools

SOPs familiarity

Excel

Job description

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. WESEEYOU. 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.

We are actively hiring a QC & Data Management Specialist II at out Walnut Creek, CA location.

LOCATION: Walnut Creek
FLSA: Non-Exempt
HOURS: Monday to Friday, Day Shift, 40 hours per week
COMPENSATION: $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.
• 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.
• Bachelor’s degree or commensurate experience.
• Minimum of 2-3+ years’ relevant experience within the field of clinical or biological research.

Knowledge and 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.
• 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.

Flourish Research offers an excellent comprehensive benefits package to include: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.

Flourish Research is an equal employmentopportunityemployer. 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 Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees.