Clinical Research Associate

2 weeks ago

Escondido, California, United States Neighborhood Healthcare Full time
Position Overview

About Neighborhood Healthcare

At Neighborhood Healthcare, we believe in empowering individuals with the resources necessary for optimal health and well-being. Our mission is to foster a community where everyone can thrive, supported by comprehensive healthcare services that cater to diverse needs. Since our inception in 1969, we have dedicated ourselves to enhancing the health and happiness of our community through accessible, quality care.

Role Summary

The Clinical Research Coordinator plays a vital role in supporting research initiatives by collaborating with Principal Investigators (PIs), sub-investigators, and various clinical departments. This position is essential for ensuring the successful execution of research studies through effective data collection and administrative support.

Key Responsibilities

Clinical Trial Management:

  • Assist in organizing and scheduling assessments and activities to align with research objectives and protocol compliance.
  • Facilitate communication among study team members to ensure adherence to study procedures and protocols.
  • Act as a liaison for participants, study personnel, Institutional Review Board (IRB), and sponsors.
  • Support the evaluation of patient eligibility and coordinate participant activities, including recruitment and screening.
  • Manage appointments and procedures, coordinating with external providers as necessary.
  • Prepare reports and materials for studies as directed.
  • Collect and manage data for research studies in accordance with established procedures.
  • Gather relevant information from participants through various methods to assist in preliminary study analysis.
  • Maintain accurate and timely records, including consent forms and regulatory documents, in compliance with institutional guidelines.
  • Assist with the submission of study reviews and amendments to the IRB.
  • Ensure that consent processes are performed in compliance with relevant regulations.
  • Provide education to study participants regarding clinical trials and any significant updates affecting their participation.
  • Prepare for monitor visits and audits by ensuring all necessary documentation is in order.
  • Collaborate with pharmacy or materials management to ensure accurate tracking of investigational products.
  • Assist with sample collection and processing for studies.
  • Update databases for reporting and compliance purposes.
  • Participate in meetings and events related to project efforts.
  • Engage in educational opportunities to enhance knowledge of clinical trials and regulations.
  • Order necessary supplies and equipment, providing recommendations for new purchases.

Team Collaboration:

  • Participate in required meetings and training sessions.
  • Maintain professional relationships with staff, participants, and the public.
  • Contribute to departmental goals and objectives.

Qualifications

  • High school diploma or GED required; bachelor’s degree preferred.
  • Certification as a Nurse Assistant or Medical Assistant required; Vocational Nurse license preferred.
  • A minimum of three years of experience in a healthcare setting is required.
  • Certification as a Clinical Research Professional or equivalent research experience preferred.
  • Certification in Human Subjects Protection or Good Clinical Practice required or to be obtained within 90 days of employment.

Skills and Abilities

  • Strong verbal and written communication skills, with attention to detail.
  • Ability to interpret various forms of instructions.
  • Familiarity with protocol design and FDA regulations.
  • Knowledge of medical research terminology.
  • Proficient in web applications and Microsoft Office.
  • Ability to collect data manually and utilize spreadsheets.
  • Strong problem-solving skills and self-management abilities.
  • Capacity to manage multiple tasks effectively.
  • Excellent organizational skills.
  • Ability to work independently and as part of a team.
  • Ability to handle confidential information professionally.

Physical Requirements

  • Ability to lift and carry up to 10 lbs.
  • Ability to stand for extended periods.

Compliance and Safety

  • Adhere to safety procedures and report any unsafe conditions.
  • Maintain knowledge of policies related to safe work practices.
  • Follow infection control procedures and maintain patient privacy.
  • Comply with all regulations regarding corporate integrity.

Neighborhood Healthcare offers a comprehensive benefits package, including medical, dental, and vision plans, vacation time, holidays, and a retirement plan.

Compensation: $34.86 per hour, based on experience.

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