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In-House Clinical Research Specialist

2 months ago

Mesa, United States Beacon Hill Full time

A highly reputable and distinguished medical device corporation is currently hiring a qualified In-House Clinical Research Specialist - II to work onsite in Mesa, Arizona.


Plan and execute clinical studies, including but not limited to, protocol & document creation, recruitment, consenting, screening, and conducting study visits. A successful professional will be knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic mindset in establishing new and creative approaches. This role will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts.


Essential Duties and Responsibilities:


  • Partner with Clinical Affairs management to develop and execute clinical studies.
  • Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines a and company SOPs
  • Execute assigned clinical trials including start up, subject recruitment & scheduling, consenting, screening, subject training, collection of regulatory documents, conducting study visits, performing SMBG testing, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports
  • Responsible for identifying and escalating safety events and major protocol deviations
  • May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager. May also propose and implement corrective and preventative actions
  • Prepare supplies and account for devices required for clinical studies
  • Set-up IT equipment for studies
  • Complete testing of electronic data capturing systems
  • Write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
  • Incorporate understanding of study objectives and key data points when planning for each assigned protocol
  • Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).
  • Communicate effectively and professionally with coworkers, leadership, and study subjects.
  • Collaborate with project management to establish and maintain study timelines
  • Clearly demonstrate understanding of clinical study management/prioritization
  • Manage all clinical tasks and deliverables to meet clinical timeline
  • Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
  • Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
  • Coordinate preparation of key documents for trial site submission to IRBs.
  • Assists management with departmental audits of clinical studies and procedures.
  • Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
  • This position assumes and performs other duties as assigned.
  • Complete tasks under minimal supervision.


Experience and Education Requirements:

  • Bachelor’s Degree in a technical discipline, and a minimum of 5 plus years related experience
  • An active medical license in good standing in the state. RN or BSN ideal. LPN, LVN, or EMT certifications.
  • Able to lead and conduct clinical study by ensuring/generating all necessary documentation including protocol, milestones, timelines, recruitment, consenting, screening, and conducting study visits.
  • Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
  • Knowledge of GCP (Good Clinical Practice)
  • Excellent communication (written and verbal) and presentation skills
  • Strong organizational skills and ability to deal with competing priorities
  • Strong critical thinking ability with the ability to work independently
  • Willing to work, hands-on, in an extremely fast paced environment with high attention to details and accuracy
  • Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams


Preferred Qualifications:

Certification as a clinical research associate or coordinator (e.g., CCRA, CCRC)

Previous experience as a MA or LVN a plus

Monitoring clinical studies experience or experience as a study coordinator is a plus

• Clinical Trial Management System (CTMS) experience.

• Experience in exercising good judgment in measuring risk vs. business needs

• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships

• Excellent organizational skills, attention to detail and a Data-driven, decision-making mindset

• Experience in continuous glucose monitoring (CGM) is a plus


Travel Required:

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