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Clinical Research Specialist

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Location: Irvine, California

Date Posted: 11 Sep, 2020

Skills:
Requires Medical Device , Pharma , TMF , Clinical


Principal duties/Roles and responsibilities::
Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities (40%)
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate re-occurrence throughout study phases (15%)
Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Client internal SOPs, and US and OUS regulations (15%)
Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas (10%) 
Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution (10%) 
Assist with clinical trials.gov updates (5%)

Required Skills/Must Have:
1. Medical Device / Pharma clinical experience 
2. Site management (in house CRA) / TMF experience 
3. Understanding clinical data 
4. Able to work onsite following the blue/green model
Education and Experience: Bachelor's Degree or equivalent in related field, 3 Years’ experience working experiences of clinical study. 
Candidate with medical device, especially cardiovascular product clinical study experience 
CLINICAL RESEARCH
CLINICAL STUDY
CLINICAL TRIAL
DOCUMENTATION
AUDITS

Preferred Skills /Desired but not required:
Clinical background, familiar with clinical study process, monitoring, GCP and clinical study relevant regulations.
High compliance requirements and understand that rights and well-being of human subjects should be protected during clinical study
FDA
GCP
SOPS
AUDIT
CARDIOVASCULAR
CLINICAL DATA MANAGEMENT
DATA MANAGEMENT
MEDICAL DEVICE


Education: Bachelors Degree