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Clinical Research Assistant 4 REMOTE
Clinical Research Assistant 4 REMOTERaland Compliance Partners • San Diego, California, USA
Clinical Research Assistant 4 REMOTE

Clinical Research Assistant 4 REMOTE

Raland Compliance Partners • San Diego, California, USA
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Position Summary :

  • The Clinical Trial Lead (CTL) / Study Lead will establish track and deliver clinical operations milestones
  • The CTL / Study Lead will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution
  • CTL / Study Lead is the single point of accountability for all stages of clinical operations activities from early study design start-up active study and close-out
  • Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines budget and milestones
  • Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations as well as software tools and systems used in clinical conduct (e.g. CTMS eCRF TMF etc.)

Essential Duties and Responsibilities :

  • Execute clinical operations deliverables for our clients products
  • Lead clinical activities directing and leading the study team as above in alignment with business goals objectives milestones and timelines
  • Collaborate with Clinical Affairs management Clinical Program Management Clinical Science Clinical Supply / Logistics Compliance and the various functional groups (R&D Biometrics Medical Affairs) as well as external contacts (study investigators and research coordinators)
  • Identify risks that may impact the overall project plan and initiate contingency plans as appropriate
  • Develop / Revise and / or provide input in the development of clinical trial related documents including but not limited to :
  • Study protocols training materials case report forms informed consents IRB submissions source documents timelines clinical monitoring plans reference manuals supply listings monitoring tools presentations meeting materials (agenda and minutes)
  • Lead functional strategy discussions study meetings and alignment meetings as needed
  • Function as a Subject Matter Expert where appropriate
  • Work independently to manage all clinical tasks and deliverables with limited oversight
  • Create and implement training programs and process improvements
  • Assists management with departmental audits of clinical studies and procedures
  • Required Knowledge / Skills / Abilities :

  • Extensive experience in all aspects of clinical trial design and execution
  • o Minimum of 8-12 years related experience in a medical device pharmaceutical IVD and / or CRO

    o Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team

  • Thorough understanding of the processes associated with study preparation study management knowledge of Good Clinical Practices (GCPs) monitoring clinical and regulatory operations
  • Technical expert in the various aspects of the clinical evaluation process
  • History of significant contribution to the success of planning and executing clinical strategies in support of product clearance
  • Strong interpersonal and communication skills
  • Excellent organizational skills and attention to detail
  • Ability to manage multiple priorities
  • Preferred Qualifications :

  • Diabetes experience desirable but not mandatory
  • Experience in the medical device industry Pharma BioTech and / or CRO
  • Experience in continuous glucose monitoring (CGM) is a plus
  • Professional certification (e.g. CCRA (ACRP) CCRP (SoCRA) PMP ACRP RAPS)
  • Travel Required :

  • The job may require travelling up to 25%-30% of the time as needed; some international travel may be required
  • Candidate Location : Remotely within United States or local to San Diego California
  • Functional / Business Knowledge

  • Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
  • Scope

  • Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods techniques and evaluation criteria for obtaining results.
  • Judgement

  • Exercises good judgment in selecting methods and techniques for obtaining solutions.
  • Normally receives little instruction on day-to-day work general instructions on new assignments.
  • Experience and Education

  • Bachelors Masters or PhD degree in a technical / scientific discipline and a minimum of 8-12 years related experience in a medical device pharmaceutical IVD and / or CRO
  • Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
  • Key Skills

    CSS,Cloud Computing,Health Education,Actuary,Building Electrician

    Employment Type : Contract

    Experience : years

    Vacancy : 1

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