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Clinical Data Coordinator I

2-4 years
Not Disclosed
10 Aug. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Fortrea: A Leader in Global Clinical Development

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Key Responsibilities

  • External Vendor Data Management: Support the Lead Data Manager (LDM) in reviewing, maintaining, and updating external vendor data received from central vendors or local laboratories. Ensure adherence to department SOPs, guidelines, and global standards to maintain data integrity and consistency across projects.
  • Data Verification: Ensure electronic vendor data contains all protocol-specified parameters, is in the correct format, and populates the specified fields and patients correctly. Assist in the development of data transfer agreements and specifications for vendor data transfers.
  • Validation and Quality Control: Support LDM in performing validation reviews of electronically transmitted data for a sample of patients in the study. Assist with reviewing external data edit checks, status reports, and data listings.
  • Local Laboratory Data Management: Interact with clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Resolve discrepancies concerning normal ranges and maintain proper documentation. Enter and perform quality control for local laboratory normal ranges, ensuring they are properly attached to patient results in the database.
  • Communication and Problem-Solving: Support LDM in communicating with vendors and clients about data transfer issues, data point problems, and validation issues, with initial oversight from senior staff. Perform other duties as required by the department.

Qualifications

  • Education: Bachelor's degree or equivalent in life sciences.
  • Experience: 2 - 4 years of experience in a similar role.
  • Skills: Strong attention to detail, excellent problem-solving abilities, and effective communication skills.

Why Join Fortrea?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employment

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Join Fortrea and make a difference in global healthcare.