QC and Data Management Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform comprehensive and precise evaluations of study charts in accordance with SOPs, policies, GCP, GDP, and sponsor protocols.

• Detect and communicate any missing or inconsistent data points and trends to the QC Manager, Team Leads, and upper management.

• Accurately input data into eCRF/CRF systems following guidelines provided by the sponsor.

• Inform the CRC and QC leadership about absent data, inconsistencies, and discrepancies between source documents and CRF/eCRF.

• Participate in Site Initiation Visits (SIV).

• Timely and accurately resolve open queries.

• Support sponsor monitor visits by assisting with query resolution.

• Collaborate professionally with colleagues and sponsor representatives.

• Aid in training and onboarding processes.

• Execute responsibilities in a time-efficient and cost-effective manner.

• Represent Flourish Research in a professional manner while engaging with staff, sponsors, IRBs, patients/subjects, and clinical personnel.

• Carry out additional tasks as assigned by management.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

• At least 1-3+ years of experience in clinical or biological research.

• Proficient in Microsoft Office applications (Outlook, Word, and Excel) and web-based applications.

• Capability to work independently and collaboratively while maintaining focus on tasks.

• Strong written and verbal communication skills.

• Effective critical thinking and problem-solving abilities.

• Professional demeanor and a strong work ethic.

• Flexibility to adapt and take on additional responsibilities as needed.

• Understanding of medical terminology and research concepts.

• Ability to engage knowledgeably and professionally with physicians, pharmaceutical sponsors/CROs, and IRBs regarding appropriate subject care.

• Some familiarity with Flourish processes.

• Basic understanding of clinical research industry guidelines and regulations.

• Capability to contribute to key initiatives and process improvements within the department.

• Ability to assist in training new hires within the company.

• Proven ability to achieve at least 80% of annual goals.

• Physical ability to lift thirty-five pounds and occasionally more than that.

• Valid driver's license and availability of a vehicle for daily use.

• Willingness to travel locally.

• Availability for occasional evening and weekend work schedules.

🏝️ Benefits

• Health, dental, and vision insurance options.

• 401(k) plan with a 100% employer match on the first 4% of employee contributions.

• Tuition reimbursement program.

• Parental leave policy.

• Employee referral program.

• Employee assistance program.

• Life insurance coverage.

• Disability insurance.

• Generous PTO plan that includes vacation, sick, personal days, and 8 paid holidays.

• Supportive and collaborative work environment.

• Numerous opportunities for growth and advancement.