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Clinical Research Specialist

2 months ago

Naples, United States TSR Consulting Services, Inc. Full time

Job ID: 78609

Job description

Main Objective:

To collaborate with clinical site coordinators on Investigator-Initiated clinical research studies from site start-up to the last follow-up visit.

Essential Duties and Responsibilities:

  • Participates in overall department strategy to provide clinical data needed for regulatory submissions, publication, and supporting clinical site coordinators.
  • Manage Investigator-Initiated clinical research studies.
  • Evaluates and analyzes clinical data.
  • Collaborate with key opinion leaders to identify issues or barriers related to the research request execution.
  • Lead required cross-functional research meetings to discuss studies and get input from product managers.
  • Track and report on the progress of assigned clinical studies, including budget and timelines.
  • Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
  • Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in the A/P system within compliance guidelines.
  • Manage data collection compliance via tracked milestones.
  • Responsible for the execution of clinical projects while adhering to budget, scope and schedule requirements.
  • Lead clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements.
  • Lead clinical budget negotiations for the purpose of executing a clinical study.
  • Assist site coordinators with IRB submissions as necessary.
  • Shows initiative to identify and implement ways to improve jobs and surroundings.
  • Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP’s and Standard Operating Procedures.
  • Maintain a high level of professional expertise through familiarity with scientific literature and product portfolio.
  • Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment. Build and maintain excellent working relationships with clinical site staff, key opinion leaders and colleagues.


Education and Experience:

  • Bachelor’s degree required.
  • Familiarity with orthopedic terminology is preferred
  • 4 years of relevant clinical research experience required
  • One year of industry sponsored or CRO employment preferred
  • Clinical Research Certification is required or obtains in one year.


Knowledge and Skill Requirements/Specialized Courses and/or Training:

Strong communication, documentation, and record-keeping skills are required. A basic ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required. The ability to read surgical techniques and have a basic understanding of the instruments necessary to perform the procedure is preferred. Attention to detail and the ability to review protocols and agreements for accuracy are required. The ability to work as a team and contribute to the goals of the group, department, and company is required.


Machine, Tools, and/or Equipment Skills:

Experience in Microsoft Office is required. Experience with clinical trial databases (EDC, CTMS, eTMF) is required.


Reasoning Ability:

Ability to prioritize and manage multiple tasks. Ability to solve problems and deal with numerous variables.

High attention to detail and the ability to edit documents.

Job Types: Full-time, Contract


Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Paid time off
  • Relocation assistance
  • Tuition reimbursement
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Work Location: In person