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Clinical Research Coordinator

Evolution Research Group

Delray Beach, Florida, United States · На постоянной основе

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Опыт
1–2 года
Зарплата
Открытия
1
Опубликовано
7 спокойно
Режим работы
В офисе
Образование
High School Diploma or equivalent (college degree preferred)
Резюме
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Где вы будете работать

Описание работы

About Evolution Research Group

Evolution Research Group (ERG), founded in 2014, is a prominent neuroscience clinical development organization specializing in Phases I through IV clinical trials. With affiliate locations nationwide, ERG is distinguished by its expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic conditions. Having completed over 5,000 studies, ERG maintains a commitment to advancing critical therapeutic areas both in the U.S. and worldwide.

ERG fosters a supportive workplace culture focused on impactful research opportunities alongside experienced professionals. The company offers competitive employee benefits including medical and dental plans, a 401(k) matching program, and paid time off for personal renewal.

Role Overview

The Clinical Research Coordinator (CRC) manages the comprehensive coordination and execution of clinical trials, ensuring adherence to protocol guidelines and regulatory standards. The CRC conducts study procedures, oversees medication distribution, and maintains precise documentation of participant data under the supervision of the Principal Investigator and Site Director. Core governance follows FDA regulations, Good Clinical Practice (GCP), and company policies.

Key Responsibilities

  • Gain thorough understanding of study protocols through review sessions with leadership before trial commencement.
  • Assist in drafting and validating source documents for accuracy ahead of trial startup.
  • Collaborate with Principal Investigator and Site Director to clarify any study components prior to initiation.
  • Oversee study compliance and operations under guidance from management.
  • Coordinate enrollment strategies alongside the Recruitment Manager and leadership team.
  • Participate in reviewing and updating standard operating procedures as assigned.
  • Perform clinical trial tasks as assigned by Principal Investigator and supervised by Site Director.
  • Attend investigator meetings relevant to assigned protocols as directed.
  • Ensure adherence to protocol requirements and document any violations promptly, reporting these to sponsors, Institutional Review Boards (IRBs), and regulatory bodies.
  • Screen and enroll participants; schedule visits collaboratively with PI.
  • Obtain and review informed consent from prospective study subjects.
  • Maintain clear records of all communications with sponsors, labs, IRBs, and regulatory entities.
  • Preserve organized and complete study files.
  • Support the Principal Investigator in conducting studies safeguarding data integrity and participant safety.
  • Accurately input data per protocol using paper or electronic data capture systems.
  • Report and monitor adverse events according to protocol definitions in coordination with PI.
  • Complete study closeout tasks and correctly store study documentation.
  • Adapt responsibilities as necessary to meet organizational goals.

Qualifications and Skills

  • Education: Minimum of high school diploma or equivalent; college degree preferred.
  • Preferred clinical research experience of 1-2 years.
  • Ability to effectively communicate with healthcare providers, colleagues, sponsors, and other stakeholders in a professional and collaborative manner.
  • Proficient knowledge of medical terminology to facilitate communication with physician offices and laboratories.
  • Demonstrated initiative to operate independently and make sound decisions within regulatory and protocol frameworks.
  • Adaptability to changing work conditions and priorities while maintaining focus on desired outcomes.
  • Understanding of regulatory standards including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Excellent verbal, written, and interpersonal communication skills.
  • Basic computer literacy, including proficiency in Word, Excel, and clinical research software such as Study Manager.

Additional Information

The position offers comprehensive benefits such as medical and dental coverage, a matching 401(k) plan, and paid time off designed to support wellbeing. The role is full-time and requires onsite presence at ERG’s Delray Beach, FL location.

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