Clinical Research Associate I Full-time NEW

Clinical Research Associate I

This is a grant-funded position with an end date of September 1, 2027, renewable based upon availability of funding, work performance, and progress toward research goals.

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.

A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.

Responsibilities

Site Management & Study Execution

• Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.
• Ensure compliance with study protocols and regulatory requirements.
• Manage site performance and resolve issues.
• Administer questionnaires, collect medical history, and perform study procedures.
• Maintain rapport with participants to support retention and address concerns.
• Obtain informed consent and ensure participant safety throughout protocol procedures.
• Coordinate with affiliated departments and external collaborators.

Data Collection & Management

• Collect and verify data from clinical sites.
• Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).
• Review and resolve data queries.
• Assist with manuscript and grant preparation, including opportunities for authorship.
• Maintain and update study databases and data collection forms.

Regulatory Compliance & Oversight

• Ensure 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.
• Prepare and maintain regulatory documents.
• Coordinate with ethics committees to safeguard participant rights.
• Participate in internal and external audits and protocol reviews.

Participant Recruitment & Retention

• Evaluate medical records and perform screenings to identify eligible study participants.
• Assist in screening and enrolling study participants.
• Maintain communication with participants to support retention.
• Address participant concerns and inquiries.

Reporting & Documentation

• Prepare study reports and documentation.
• Maintain accurate records of study activities.
• Assist in the preparation of manuscripts and publications.

Marginal or Periodic Functions

• Conduct literature reviews to support study design and protocol development.
• Assist in training new site staff and research team members.
• Participate in internal and external audits.
• Support development of study protocols and case report forms.
• Attend conferences and workshops to stay updated on industry trends.
• Adhere to internal controls and reporting structure.
• Perform related duties as required.

Knowledge, Skills, and Abilities

• Maintain organized records, follow detailed procedures, and double-check work for accuracy.
• Write clear and concise reports, actively listen, and present information effectively.
• Analyze information, develop solutions, and implement corrective actions.
• Collaborate with team members and support team decisions.
• Prioritize tasks, set realistic deadlines, and manage time effectively.

Required Qualifications

• Bachelor's degree in life sciences, nursing, or a related field
• One year of relevant clinical research experience
• Familiarity with IRB processes and human subjects protection standards
• Experience with electronic data capture systems (e.g., REDCap)

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 two years of clinical research experience, preferably involving pediatric or neurodevelopmental populations
• Experience with statistical software (e.g., R, SAS, SPSS)
• Experience presenting research findings or contributing to publications
• Completion of Human Subjects Protection Training
• Experience working with children and families affected by neurodevelopmental disorders
• Strong written and verbal communication skills
• Ability to abstract data from medical records and manage complex databases
• Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)

Working Conditions

• May work around standard office conditions
• Repetitive use of a keyboard at a workstation
• Occasional weekend, overtime, and evening work to meet deadlines
• Occasional interstate, intrastate, and international travel
• This position will be assigned on-campus with an expectation to report to work on-site during the scheduled work week.

Required Materials

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