Clinical Research Associate I

Clinical Research Associate I

This is a grant funded position with an end date of 12/31/2026, renewable based upon availability of funding, work performance, and progress toward research goals. The Clinical Research Associate I will manage and oversee day to day coordination and operations of assigned clinical research projects within the Psychiatry and Behavioral Sciences department. This role involves a significant focus on recruitment, enrollment and research activities for clinical research.

The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.

Site Management

• Conducts site initiation, monitoring, and close-out visits.
• Ensures compliance with study protocols and regulatory requirements.
• Manages site performance and resolves issues.
• Supports participant coordination and visit management, including scheduling, visit reminders, and reimbursement processes under PI or senior staff oversight.
• Coordinates with clinical staff for specimen collection and protocol-required procedures.

Data Collection and Management

• Collects and verifies data from clinical sites.
• Ensures accurate and timely data entry into electronic data capture systems.
• Reviews and resolves data queries.
• Assists with quality control and maintains study binders and source documentation in accordance with GCP and FDA regulations.

Regulatory Compliance

• Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.
• Prepares and maintains regulatory documents.
• Coordinates with ethics committees to safeguard participant rights.
• Supports regulatory start-up activities and assists with IRB amendments under supervision.

Participant Recruitment and Retention

• Evaluates medical records and performs screenings to identify eligible study participants.
• Assists in screening and enrolling study participants.
• Maintains communication with participants to ensure retention.
• Addresses participant concerns and queries.
• Supports recruitment outreach and preliminary screenings under guidance of senior staff

Reporting and Documentation

• Prepares study reports and documentation.
• Maintains accurate records of study activities.
• Assists in the preparation of manuscripts and publications.

Marginal or Periodic Functions

• Conducts literature reviews to support study design and protocol development.
• Assists in the training of new site staff and research team members.
• Participates in internal and external audits.
• Supports the development of study protocols and case report forms.
• Attends conferences and workshops to stay updated on industry trends.
• Performs other tasks as assigned to support research team and project goals
• Adheres to internal controls and reporting structure.
• Performs related duties as required.

Knowledge/Skills/Abilities

• Double-checks work for errors, maintains organized records, and follows detailed procedures.
• Writes clear and concise reports, actively listens to others, and presents information effectively.
• Analyzes information, develops solutions, and implements corrective actions.
• Shares information, supports team decisions, and contributes to team success.
• Prioritizes tasks, sets realistic deadlines, and uses time efficiently.
• Basic proficiency in Microsoft Office Suite (Word, Excel, Outlook). Familiarity with data entry platforms such as REDCap or ability and willingness to learn.
• Demonstrated ability to collaborate effectively with participants, clinical staff, and research teams.
• Detail-oriented with strong time management; able to follow protocols and maintain regulatory compliance.

Required Qualifications

• Requires a Bachelor's Degree in life sciences, nursing, or a related field.
• 1 year of relevant clinical research experience.
• Relevant education and experience may be substituted as appropriate

Preferred Qualifications

• Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in clinical research experience.
• Experience in research or healthcare environment (e.g., internships, volunteer roles, or academic projects).
• Good Clinical Practice (GCP) Certification: Demonstrates understanding of GCP guidelines.

Licenses, Registrations or Certifications

• None

Preferred:

• Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).
• CITI Human Subjects Research Training.
• GCP (Good Clinical Practice) certification.

Salary Range

$40,000 + depending on qualifications

Working Conditions

• May work around chemical fumes
• May work around standard office conditions
• May work around biohazards
• May work around chemicals
• Repetitive use of a keyboard at a workstation
• Use of manual dexterity
• Climbing of stairs
• Climbing of ladders
• Lifting and moving
• Occasional weekend, overtime and evening work to meet deadlines

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest