Senior Clinical Research Associate - Hybrid Trials

CTI; Covington (KY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Career progression

Tuition reimbursement

Hybrid work options

Paid parental leave

Health benefits

Job summary

CTI in Covington, KY seeks a Clinical Research Associate to monitor phase I–IV and Real World Evidence studies, ensuring adherence to ICH GCP and SOPs. You will serve as the CTI contact for study sites, perform PSV/SIV/IMV/COV visits, and support regulatory documents and IP accountability.

The role requires at least 1 year of on-site monitoring and a related degree; CTI offers career growth, training, health benefits, and hybrid work options.

Qualifications

• At least 1 year of clinical trial monitoring experience or equivalent.
• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience.
• Previous experience in conducting clinical research studies in a hospital setting, a pharmaceutical company, or a CRO.
• Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred.

Responsibilities

• Serve as the main CTI contact for assigned study sites and conduct site visits (PSV/SIV/IMV/COV) with quality deliverables.
• Collect, review, and track essential regulatory documents and IP; ensure proper storage and accountability.
• Assist with study start-up activities like feasibility and site selection; participate in meetings with investigators and clients.
• Mentor and train site staff; liaise with Clinical Data Management for data cleaning and SDV activities.
• Manage ISF and TMF per SOPs; support regulatory submissions and ethics committee communications.

Skills

Clinical monitoring

Site management

GCP/ICH knowledge

Education

Bachelor's Degree or higher in allied health

RN with an Associate's Degree

Nursing Diploma with 2+ years clinical nursing experience

Job description

CTI in Covington, KY seeks a Clinical Research Associate to monitor phase I–IV and Real World Evidence studies, ensuring adherence to ICH GCP and SOPs. You will serve as the CTI contact for study sites, perform PSV/SIV/IMV/COV visits, and support regulatory documents and IP accountability.

The role requires at least 1 year of on-site monitoring and a related degree; CTI offers career growth, training, health benefits, and hybrid work options.