ALLEN SPOLDEN ajută organizațiile din domeniul farmaceutic, al biotehnologiei, al asistenței medicale și al sănătății publice să construiască și să sprijine echipele care susțin cercetarea clinică. Soluțiile sale pentru forța de muncă și cercetare includ servicii de suport oferite de furnizori specializați, gestionarea datelor clinice, îndrumare în domeniul reglementărilor și recrutarea de personal specializat, adaptată nevoilor proiectului. Prin combinarea expertizei sectoriale cu sprijinul operațional, compania ajută echipele care desfășoară studii clinice să lucreze mai eficient, menținând în același timp productivitatea și conformitatea în cadrul operațiunilor de cercetare.
Clinical Data Reviewer - Remote in the United States
Review clinical and laboratory data for a global clinical research organization. Investigate discrepancies, issue site queries, and help maintain audit-ready trial records.
Descriere
- Evaluate clinical and laboratory data for accuracy, consistency, and completeness
- Investigate discrepancies that require clarification from study sites
- Use clinical, laboratory, or patient-care knowledge to detect implausible or inconsistent information
- Prepare and send site data queries using approved guidelines and templates
- Compare laboratory results with concomitant medications, adverse events, and medical history
- Review medical coding under the direction of senior reviewers
- Identify data quality patterns, protocol compliance concerns, and training requirements
- Maintain audit readiness by following SOPs and keeping documentation accurate
- Take part in Protocol Deviation, Data Review and Quality Team (DRQT), and Safety Monitoring Team (SMT) meetings
- Prepare listings, trackers, and presentation slides for data review meetings
Cerințe
- Associate-level or bachelor's education, or a relevant diploma or certificate combined with practical experience, in life sciences, laboratory science, or an allied health discipline
- Up to two years of experience in a clinical, laboratory, dental, or healthcare environment, including internships, clinical placements, or externships
- Ability to read and interpret patient information such as vital signs, laboratory values, medication and allergy lists, treatment or procedure notes, and charts
- Working knowledge of medical terminology and precise documentation practices
- Strong written and verbal English communication skills with careful attention to detail
- Well organized, with the ability to manage several tasks and meet deadlines
- Proficiency with Microsoft Excel and other Microsoft Office tools
- Relevant certification or licensure is preferred
- Experience using EHR/EMR, practice management, or LIMS systems is preferred
- Interest in oncology or another clinical specialty is preferred
Beneficii
- Training in clinical trial processes, clinical database navigation, query development, and medical coding
- Mentorship to support skill and confidence development
- Remote work arrangement