CRA II: Flexible Work & Growth in Clinical Trials

Novotech; Nashville (TN); On-site; USD 70,000 - 140,000; Full time

Job summary

Novotech is seeking a Clinical Research Associate (CRA) to protect participant rights and ensure accurate, complete trial data across sites. The CRA is the primary contact between Investigational Sites, Novotech, and Sponsor, ensuring adherence to ICH GCP and SOPs.

The role includes building relationships with site personnel, supporting regulatory submissions, monitoring visits (onsite or remote), site recruitment plans, and timely study progress reporting.

Qualifications

• Graduate in a clinical or life sciences-related field.
• CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience in other roles in the Clinical industry.
• CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
• Sr. CRA: At least 3-5 years of Clinical Research Associate experience in the Clinical industry.
• Salary Band - $70,000 - 140,000 Salary offered will be based on candidates experience level.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient management of clinical trials.
• Foster internal and external customer relationships to ensure timely and productive project delivery.
• Prepare site essential documents and support ethics and regulatory submission processes as needed.
• Understand regulatory requirements relevant to specific trials and ensure site recruitment targets are met.
• Monitor investigational sites per ICH GCP and CMP, with visits onsite or remote as per plan.
• Ensure rights and wellbeing of trial participants, protocol compliance, and timely AE/SAE reporting.
• Verify data accuracy and completeness, resolve queries per timelines.
• Maintain TMF up to date and site payments handling with contract terms.
• Provide site updates and escalation of key issues per SOPs.

Skills

Clinical background

Time management

Teamwork

Computer literacy

Education

Clinical/life sciences degree

Job description

Novotech is seeking a Clinical Research Associate (CRA) to protect participant rights and ensure accurate, complete trial data across sites. The CRA is the primary contact between Investigational Sites, Novotech, and Sponsor, ensuring adherence to ICH GCP and SOPs.

The role includes building relationships with site personnel, supporting regulatory submissions, monitoring visits (onsite or remote), site recruitment plans, and timely study progress reporting.