Jobs · Analyst · Pennsylvania

Clinical Research Coordinator

Lexitas Pharma Services · Erie, PA · 1 mo ago
On-siteAnalystFull-time

Overview

The Clinical Research Coordinator is a mission-critical role responsible for the execution and oversight of ophthalmic clinical trials. This position ensures protocol compliance, regulatory adherence, and seamless coordination of patient activities while maintaining the highest standards of care and operational efficiency.

Responsibilities

  • Operational Oversight & Protocol Adherence
    • Oversee daily execution of clinical trial activities from site initiation through close-out.
    • Ensure all procedures are conducted in accordance with study protocols and regulatory requirements.
    • Prepare for and support sponsor monitoring visits, audits, and inspections.
    • Maintain site readiness and compliance in collaboration with leadership.
  • Patient Coordination & Engagement
    • Recruit, screen, and enroll eligible patients, ensuring proper informed consent.
    • Cook up patient scheduling, diagnostic testing, and follow-up visits.
    • Monitor and report adverse events with appropriate documentation.
    • Deliver a high-quality patient experience to promote engagement and retention.
  • Regulatory & Sponsor Communication
    • Maintain essential study documentation (regulatory binders, consent forms, delegation logs, training records).
    • Serve as liaison with sponsors, CROs, and internal departments.
    • Prepare and submit IRB documentation including amendments and renewals.
  • Cross-Functional Collaboration
    • Partner with physicians, technicians, medical assistants, and administrative teams.
    • Participate in investigator meetings, training, and team discussions.
    • Support overall clinical and operational excellence in study execution.

Requirements

  • Education:
    • Average Associate’s or Bachelor’s degree in Life Sciences, Healthcare, or related field preferred
  • Experience:
    • 2+ years of clinical research or healthcare experience preferred
    • Experience coordinating clinical trials strongly preferred
    • Ophthalmology or specialty clinic experience is a plus
  • Certifications:
    • Clinical Research Coordinator (CRC), CCRA, or similar certification preferred but not required
    • Good Clinical Practice (GCP) training required
  • Skills:
    • Strong knowledge of clinical research processes and regulatory requirements
    • Excellent organizational and multitasking abilities
    • Strong attention to detail and documentation accuracy
    • Effective communication and interpersonal skills
    • Ability to coordinate across cross-functional teams
    • Proficiency with EDC systems and Microsoft Office tools

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Pay Range

22 - 26 USD per hour (Erie)

Contact Information

Erie Retina Research
Erie, PA

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