Clinical Research Specialist in Irvine, CA at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/9/2018
  • Job ID:
    875478

Job Description


Clinical Trial Research Specialist

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

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

Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases

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, internal SOPs, and US and OUS regulations

Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

Works independently without close supervision

Compares and evaluates possible courses of action after considering various possibilities       

Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met                  

Determines or effectively recommends course of action after considering potential risks of alternatives       

May provide guidance to lower level personnel 

Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment            

Direction tends to be high level and focused on end results with means of accomplishment left to incumbent

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

Excellent written and verbal communication skills and interpersonal relationship skills

Excellent problem-solving and critical thinking skills

Solid knowledge and understanding of company policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

Solid 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 inter-departmental teams and representing the organization on specific projects

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

Education and Experience:

Bachelor's Degree or equivalent in related field

3 Years years experience working experiences of clinical study.

Candidate with medical device, especially cardiovascular product clinical study experience

Required Additional Skills:

• 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

To apply for this position please contact or send CV to Vickie Dagit, vdagit@apexlifesciences.com

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.