Job Description

Job Overview

We are seeking a dedicated and detail-oriented Clinical Trial Coordinator to join our dynamic team. The ideal candidate will play a crucial role in the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and Good Clinical Practice (GCP). This position requires strong organizational skills, an understanding of medical terminology, and the ability to work collaboratively with healthcare professionals and research teams.

Responsibilities

Oversee the coordination of clinical trials from initiation through completion, ensuring adherence to protocol and regulatory requirements. Supervise clinical trial staff and manage daily operations of the trial site. Review documentation for accuracy and compliance with FDA regulations and CDISC standards. Monitor patient progress throughout the trial, including conducting assessments of vital signs and collecting blood samples as needed. Manage data collection processes, ensuring accurate data entry into electronic medical record (EMR) systems and statistical software. Collaborate with clinical research teams to develop study protocols and informed consent documents. Conduct training sessions for staff on clinical trials management, compliance management, and Good Clinical Practice (GCP). Maintain up-to-date knowledge of clinical development processes and regulatory changes affecting clinical trials. Proven experience in clinical trials management or related field is essential. Familiarity with medical terminology, patient monitoring techniques, and phlebotomy practices is required. Experience with documentation review, data management, and analysis skills is critical for success in this role. Knowledge of FDA regulations, HIPAA compliance, and good clinical practices is necessary.

Key Responsibilities

1. Study Operations & Regulatory Compliance

-Oversee IRB submissions and renewals. Assist with protocol amendment and review.

- Ensure compliance with all regulatory, institutional, and sponsor requirements for clinical research, including informed consent management and patient confidentiality.

- Manage electronic and physical study documentation and payment procedures.

2. Recruitment, Consent, and Scheduling

-Coordinate subject screening, recruitment, and enrollment; explain trial details and ensure thorough informed consent which is well documented and timely.

-Oversee scheduling of assessments, sample collection, biomarker studies, and intervention visits.

-Coordinate with investigators, laboratory and participants for all procedures

-Maintain flexibility with rescheduling procedures when necessary, maintaining good communication.

3. Data & Specimen Management

-Ensure accuracy, timely data entry and timely submission of case report forms and study documents.

- Oversee the proper collection, labeling, and shipment of labs, biospecimens, and data for all studies.

4. Supervisory and Team Coordination

-Mentor and supervise (a) assistant(s), including hands-on training in regulatory compliance, data handling, and participant management. Ensure assistant(s) provide high quality, accurate work.

- Schedule and document meetings; facilitate collaboration among investigators, clinicians, research staff.

5. Investigator & Sponsor Liaison

-Serve as primary contact for investigators, sponsors, and collaborators; update stakeholders on progress and protocol changes.

-Facilitate collaborative efforts, including multicenter study harmonization and integration of new technology (digital consent, virtual meetings).

6. Reporting, Safety & Quality Assurance

-Track, report, and document adverse events, protocol deviations, and compliance issues; ensure prompt notification to investigators and IRB.

-Contribute to quality assurance audits and facilitate corrections of any monitoring/audit findings.

7. Dissemination & Publication Support

-Assist with the preparation of progress reports, presentations, and manuscripts for scientific publication.

Required Qualifications & Skills

*Bachelor's degree in biological sciences, psychology, or related field; higher degree preferred.

*Experience in clinical trial management, preferably with autism/neurodevelopmental populations.

*Familiarity with clinical data systems, electronic databases, and biomarker/lab protocols.

*Excellent organizational, supervisory, and communication skills--including remote collaboration.

*Knowledge of GCP, HIPAA/GDPR, and human research ethics.

Additional Notes

- Some evenings or weekends may be required for participant visits or study meetings.

- Must foster a supportive, inclusive environment for research subjects and team members.

Job Type: Full-time

Pay: $50,966.85 - $61,379.43 per year

Education:

Bachelor's (Required)
Experience:

Clinical trials management: 1 year (Required)
Ability to Commute:

Phoenix, AZ 85050 (Required)
Work Location: In person