Clinical Data Specialist

Celerion; Tempe (AZ); On-site; USD 24,000 - 35,000; Full time

Job summary

Celerion in Tempe, AZ is seeking a detail-oriented QC/Data Entry associate to review source data and ensure accurate CRF data entry for regulatory reporting. You will support study setup, data cleaning, and ongoing QC activities in a fast-paced clinical trials environment.

Requirements include a High School Diploma or GED, 1–2 years of relevant experience, proficiency with MS Office, and strong written and verbal communication. Attention to detail and multi-tasking are essential to succeed.

Qualifications

• Minimum education: High School Diploma or GED.
• 1–2 years industry experience preferred.
• Previous QC/Data Entry or related experience preferred.
• Medical Terminology Training preferred.
• Excellent oral and written communication skills.
• Ability to organize and manage multiple priorities.
• Experience with complex processes and defined criteria.
• Excellent time management skills required.

Responsibilities

• Attend study setup meetings to determine QC criteria and timelines.
• Review study-specific source documents for accuracy and protocol conformity.
• Ensure QC reviews are completed on time per study timelines.
• Review source data for completeness and adherence to GCP/FDA guidelines.
• Perform accurate data entry and verification for EC/CRFs.
• Archive source documentation including CRFs.
• Complete QC/DE milestones in a timely manner.
• Perform standard quality control steps.

Skills

Attention to detail

Oral and written communication

Time management

Organizational skills

MS Office proficiency

Education

High School Diploma or GED

Tools

MS Office

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Responsible for the review of all source data and ensure all applicable data is entered into its respective database and/or Case Report Form (CRF). Ensure the completeness, accuracy, and consistency of source data and CRF data entry so that it meets the standard of quality expected for reporting to Sponsors and regulatory bodies. Participate with auxiliary teams involved in study set up, conduct, and data cleaning of clinical trials.

Essential Functions

• Attend study setup meetings to determine QC criteria and timelines for each study
• Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements.
• Ensure QC reviews are complete in accordance with study-specific timelines
• Review source data on an ongoing basis to ensure the following: Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs. Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs. Complete a Final QC to ensure all source data is accounted for and has been QC reviewed
• Perform accurate data entry and verification for Celerion Standard and Sponsor Provided EDCs.
• Archive source documentation including CRFs
• Complete QC/DE dedicated milestones in a timely manner
• Perform standard quality control steps

Requirements

• High School Diploma or GED (relevant internal Celerion experience in lieu preferred)
• 1 - 2 years industry experience preferred
• Previous Quality Control/ Data Entry or related experience preferred
• Medical Terminology Training preferred
• Excellent oral and written communication skills
• Ability to organize and manage multiple priorities
• Experience working in an environment with complex processes and defined criteria
• Excellent time management skills required
• Proficient in MS Office applications required
• Excellent attention to detail skills required

$21.50 - $21.50 an hour

Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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