Associate clinical research specialist Irvine, CA

vishalk@enterprisesolutioninc.com

Job title: Associate clinical research specialist

Job Location: Irvine, CA, 92614

Job Duration: 12+Months 

Pay Rate: $39.28/hr. on w2

Duties: 

•             This position and rate are considered a "CRA I"

•             Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements

•             Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)

•             Conduct reviews of documentation needed for 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, Edwards internal SOPs, and US and OUS regulations

•             Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout

•             Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas

•             Assist with ECR submissions in Ignite 

Skills:    

Top Requirements: 

•             Medical Device / Pharma clinical experience

•             Site management (in house CRA) / TMF experience, study start-up experience

•             Understanding clinical data 

•             Able to work onsite at could be partial to start but fully onsite later in the year, as required

•             Excellent communication and collaboration skills

•             Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.

•             Good written and verbal communication skills and interpersonal relationship skills

•             Good problem-solving and critical thinking skills

•             Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

•             Good understanding of regulatory submissions, reporting, and audits

•             Ability to manage confidential information with discretion Strict attention to detail

•             Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment

•             Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

•             Ability to build productive internal/external working relationships

•             Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

•             Local candidates are needed to work onsite.

Education:          

•             Bachelor's Degree in related field of study and MINIMUM 1 year of of previous experience as a clinical research associate. 

•             HIGHLY PREFER 2 years or more.