Clinical Research Associate

Huntington Study Group is hiring for a Clinical Research Associate. This is not a Senior Clinical Research Associate position.

Position Summary:

A dynamic organization is seeking an experienced Clinical Research Associate (CRA) to review investigative sites and site compliance with clinical trial protocols through both on-site and remote monitoring via electronic data capture system review. The CRA will assist in determining clinical trial site compliance as it pertains to both specific clinical trial protocol(s) and compliance with applicable regulations. The CRA is an integral part of the clinical trial team and as such assists in study startup process will provide documents for the central regulatory file, will create monitoring reports and follow-up with communications to sites. The CRA may participate in team meetings on an ad hoc basis and will participate in reconciliation of data including serious adverse events and other reportable events with adverse event, dose management, and other relevant study records. The CRA must stay abreast with and present new regulatory information as applicable to both internal and external stakeholders. This position may be assigned to multiple trials at one time and will work very closely with the Project Teams managing the day-to-day study operations. Depending on the experience of the individual, the degree of responsibility will vary with immediate direction and supervision provided by the Senior or Lead Project Manager for the specific clinical trial that the CRA is assigned to. The position will report to the Senior Manager, Clinical Operations Monitoring.

Principal Duties and Responsibilities:

• Assists in study startup process (e.g., initiation of new sites, training of monitors, development of monitoring plan, site staff training, acquisition of clinical supplies, regulatory compliance i.e., IRB, FDA, GCP etc.)
• May participate in team meetings on an ad hoc basis at various stages of the study (e.g., to present and review the monitoring plan prior to study start-up, to discuss site performance issues based on monitoring visits, etc.)
• Ensures effective site management by overseeing regulatory compliance, site training, and data quality to support study success.
• Provides guidance on informed consent processes, investigator site file (ISF) maintenance, and site readiness for monitoring visits.
• Reviews investigative sites and site compliance with clinical trial protocols through on-site and remote monitoring via electronic data capture system
• Works closely with monitors and study teams to track and resolve site-level issues, ensuring compliance with GCP and study protocols.
• Collaborates with site personnel to address protocol adherence, recruitment challenges, and ongoing site performance improvements
• Stays abreast with and presents new regulatory information as applicable to both internal and external stakeholders
• Provides documents for the central regulatory file, review, tracking and storage of regulatory documents required in a clinical trial, e.g., FDA 1572, IRB approval etc.
• Creates monitoring reports and follow-up communications to sites
• Participates in reconciliation of data including serious adverse events and other reportable events with adverse event, dose management, and other relevant study records
• Collaborate with Project Managers and relevant study team members to ensure that the study and sites are performing and documenting study activities consistent with Good Clinical Practice and Standard Operating Procedures.
• May perform other study- or organization-specific duties of similar scope and complexity
• Perform all other duties and tasks, as assigned by the Manager

Required Education and Experience:

• Bachelor’s degree, with major coursework in health, social science or biological science field or equivalent combination of education and experience
• Knowledge of Good Clinical Practice (GCP), protocol planning, implementation, coordination, evaluation and reporting of clinical trials.
• Clinical trials monitor experience required.
• Travel required up to 80%, as applicable.
• Strong oral and writing skills with attention to detail and organization is required.
• Desire to make a difference in the health and well-being of a global population.

Competencies/Skills:

• Excellent organizational, written and verbal communication skills
• Excellent interpersonal skills, ability to follow-up with clinical sites in regards to completeness of regulatory documents
• Proficient in MS Office products – Word, Excel, Access (or other database software, i.e. Smartsheet)
• Ability to perform comfortably in a fast-paced, deadline-oriented work environment
• Ability to work as a team member, as well as independently

Physical Demands:

• While performing the duties of this job, the employee is regularly required to talk and hear. This position requires standing, sitting, walking and carrying. The employee must be able to lift up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

• This position consists mostly of working remotely.
• Working conditions must have sufficient Wi-Fi and lighting

Position Type and Expected Hours of Work:

Full-Time, Exempt remote position working Monday through Friday 8:00am to 5:00pm, with work on weekends and at night as needed.

EOE Statement:

HSG is an Equal Opportunity Employer. Employment opportunities at HSG are based upon one's qualifications and capabilities to perform the essential functions of a particular job. All employment opportunities are provided without regard to race, religion, sex, pregnancy, childbirth or related medical conditions, national origin, age, veteran status, disability, genetic information, or any other characteristic protected by law.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Remote