The Clinical Project Management Assistant , following study specific guidelines, ensures data collected during clinical trials is processed completely and accurately. Performs duties in accordance with company’s values, policies, and procedures.
The CPMA performs the following functions:
Independently and accurately performs clinical data entry, following study specific guidelines and training.
Responsible for the transcription of study data from source documents to paper or electronic Case Report Forms (CRF’s). In addition, performs verification and resolution of discrepancies within defined timelines. Accurately logs and tracks Case Report Forms and Queries.
Assists Project Managers in tracking and resolving CRF’s and query metrics Understands and complies with Good Clinical Practices (GCP’s) particularly regarding protection and integrity of study participant and clinical trial data. Complies with all HIPAA and other regulatory policies.
Understands and complies with Profil’s Standard Operating Procedures (SOPs) and Work Instructions (WIs) Participates, as requested, in Profil’s Continuous Quality Improvement (CQI) process
High school diploma or general education degree (GED); 1 -2 years work experience (health service industry preferred).
Excellent computer skills with working knowledge and proficiency in Microsoft Office 97-2010 Word, Excel, and PowerPoint as well as Window applications.
Ability to independently and accurately perform clinical data entry following study specific guidelines and training in addition to performing verification and resolution of discrepancies within defined timelines.
Ability to record study data accurately and legibly.
Ability to understand and follow oral and written instructions precisely. Ability to communicate effectively with co-workers and sponsor representatives.
Ability to work in a fast-paced environment and can adapt easily to changing priorities.