Lead Clinical Research Specialist

1 week ago

Fort Lauderdale, Florida, United States Life Extension Full time

Lead Clinical Research Specialist Job Post

  • Are you a meticulous Clinical Research expert seeking a fulfilling career opportunity?
  • Do you possess a minimum of 3 years of experience in Clinical Trials involving human participants?
  • Are you open to a hybrid work arrangement?
  • Are you interested in a company that offers a comprehensive benefits package, competitive compensation, and a service-oriented workplace culture?

If you answered yes, this position may be ideal for you.

Life Extension, a leading vitamin and supplement organization, is in search of a Lead Clinical Research Specialist. Below is the detailed job description and application information.

Overview: This role involves coordinating and facilitating daily clinical trial operations, playing a vital role in study execution, including participant recruitment. You will collaborate with Clinical Investigators and the Clinical Research team to assist in the execution of research protocols while providing administrative and data collection support.

Key Responsibilities:

  • Exhibit comprehensive knowledge of protocol requirements and Good Clinical Practices (GCP) as mandated by federal regulations.
  • Coordinate, support, and facilitate both on-site and remote clinical studies in strict compliance with approved protocols.
  • Conduct research in alignment with Good Clinical Practice (GCP), Life Extension Clinical Research Standard Operating Procedures, and relevant local, state, and federal regulations.
  • Monitor protocol implementation and study progression, keeping the team informed through participation in meetings.
  • Provide quality assurance and quality control for clinical studies, ensuring adherence to protocols and making recommendations for improvements.
  • Assist in recruitment and retention efforts, including scheduling appointments, obtaining consent, enrollment, follow-up, and data management while adhering to project timelines.
  • Play an active role in successfully recruiting and enrolling participants for clinical studies.
  • Collaborate with marketing to promote clinical research initiatives, providing evaluation and input.
  • Perform clinical tasks such as managing study products, laboratory specimen handling, and timely documentation of adverse events.
  • Oversee sample processing, packing, and shipping in accordance with protocols and applicable standards.
  • Ensure data integrity and management, completing documentation from source documents and laboratory reports promptly.
  • Support the revision and consolidation of current SOPs and Work Instructions to ensure compliance with current practices and regulations.
  • Assist in assessing and implementing CTMS systems and software to enhance efficiency, quality, and reporting for clinical trials.
  • Oversee the preparation of source and data documentation, whether in paper or electronic format, ensuring timely adverse event reporting.
  • Maintain regulatory files for completeness in collaboration with the Clinical Research Supervisor and team.
  • Work with the Director and Clinical Research Supervisor to design, coordinate, and implement all research projects.
  • Train staff on compliance with protocols and federal and institutional requirements.
  • Assist in the preparation of study product doses, ensuring secure receipt, inventory, and storage; assist with dispensing study products with proper documentation.
  • Report any quality or participant safety concerns to the Director.
  • Support the reporting of clinical trial progress, including metrics for participant recruitment and tracking of budgets, expenses, and participant payments.
  • Manage study materials and supplies, including distribution, ordering, tracking, storage, reconciliation, and disposal.
  • Facilitate study closeout activities and maintain records as required.
  • Recognize opportunities for personal growth, taking responsibility for enhancing skills or knowledge. Complete required continuing education training and maintain certifications as necessary.
  • Exhibit flexibility to travel as needed for participant recruitment.
  • Regular on-site attendance is essential for this position, with some flexibility for remote work after an initial period, depending on study types.
  • Other duties as assigned.

Qualifications:

  • Bachelor's degree in a relevant field.
  • Certification as a Clinical Research Coordinator from ACRP or SOCRA, or other acceptable certification from an accredited provider.
  • A minimum of 3 years' experience in clinical trials involving human subjects, database management, and regulatory compliance; additional experience is preferred.
  • Strong analytical and problem-solving abilities.
  • Comfortable working with participants both in-person and remotely.
  • Demonstrated understanding of clinical study participant recruitment, selection, and enrollment.
  • Flexible schedule to meet changing business needs and travel requirements.
  • Proficient in Microsoft Office Suite.
  • Familiarity with clinical research software, including clinical trial management systems and electronic data capture.
  • Ability to handle confidential information with discretion.
  • Detail-oriented with the ability to analyze, organize, and prioritize tasks in a fast-paced environment.
  • Ability to perform various physical tasks, including standing or walking for extended periods.

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