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Clinical Trial Coordinator

2+ years
$60,000/yr - $70,000/yr
15 June 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Bilingual Clinical Trial Coordinator (English/Spanish)

Location: Bloomfield, NJ

Pay Range: $60,000/yr - $70,000/yr (Exact compensation may vary based on skills, experience, and location)

Employer: [Envision Ocular, LLC]


Job Description

The Clinical Trial Coordinator works under the direction of the Principal Investigator (PI) to oversee clinical trials, ensuring adherence to Good Clinical Practice, FDA, HIPAA, OHRP, IRB, and institutional SOPs.

Essential Functions:

  • Demonstrate leadership in ethical research practices to protect patient rights and ensure quality data collection.
  • Maintain adequate inventory of study supplies, handle/dispense investigational drugs, and adhere to sponsor protocols on Investigational Drug/Device Accountability.
  • Monitor and maintain temperature logs, and provide patient teaching regarding drug administration as necessary.
  • Attend Investigator Meetings and training sessions, with occasional travel required.
  • Support regulatory staff in maintaining regulatory documents in accordance with Envision Ocular, LLC SOP and applicable regulations.
  • Perform other duties as assigned.

Qualifications:

  • Bachelor's degree in science or health-related field from a recognized college or university.
  • Minimum two years of experience in a clinical research environment (certification as a CCRC or CCRP desired).
  • Minimum one-year supervisory experience.
  • Must speak Spanish; knowledge of medical terminology, clinical medicine, clinical trials, and GCP concepts.
  • Ophthalmology experience is a plus.
  • Detail-oriented and meticulous in all aspects of work.
  • Strong follow-through skills with the ability to proactively identify and solve problems; demonstrated initiative is imperative.
  • Ability to work independently and as part of a team.
  • Capable of working well under pressure, multi-tasking, and managing deadlines.
  • Proficiency in Microsoft Office Word and Excel, electronic health systems, and research databases, or willingness to learn and demonstrate proficiency within six months of hire.

Benefits:

  • Competitive pay (based on experience).
  • PTO, Sick Leave, and Benefits.
  • 401K plan.

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Additional Information:

This position offers a competitive salary and benefits package. Exact compensation may vary based on skills, experience, and location.

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