Clinical Research Associate in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Clinical Research Associate in the United States.

This role is a field-based clinical research position focused on the independent monitoring and management of clinical trial sites, ensuring the highest standards of data integrity, regulatory compliance, and patient safety. You will be responsible for overseeing site performance across all phases of clinical studies, from start-up through close-out, within a fast-paced and highly regulated environment. The position involves frequent collaboration with investigators, site staff, and internal study teams to ensure smooth execution of protocols and adherence to GCP/ICH guidelines. You will play a key role in identifying and mitigating site risks, supporting audit readiness, and maintaining high-quality trial documentation. This is a highly autonomous role requiring strong attention to detail, excellent communication skills, and the ability to manage multiple sites and priorities. The position requires meaningful travel and offers exposure to complex therapeutic areas, including oncology and rare diseases.

• Oversee all aspects of clinical trial site management to ensure patient safety, data integrity, and compliance with protocols, GCP, and regulatory requirements.
• Conduct all types of site visits including qualification, initiation, monitoring, and close-out visits, both on-site and remotely.
• Manage study start-up activities when required, including feasibility assessments, regulatory submissions, and informed consent documentation.
• Perform ongoing review of Investigator Site Files (ISF) and reconciliation with Trial Master Files (TMF).
• Support audit readiness activities and provide guidance on quality assurance standards at site and study levels.
• Monitor investigational product (IP) handling, including accountability, storage, dispensing, and reconciliation.
• Perform data review in EDC systems, resolve queries, and collaborate with data management teams to ensure data accuracy.
• Identify, document, and escalate protocol deviations, safety issues, and Serious Adverse Events (SAEs) as required.
• Prepare detailed monitoring reports, follow-up communications, and documentation in accordance with SOPs and study requirements.
• Build and maintain strong relationships with investigators and site personnel while supporting recruitment and retention efforts.

• Bachelor’s degree in a scientific, healthcare, or related discipline (or equivalent experience).
• Minimum of 2 years of experience as a Clinical Research Associate in a CRO, biotech, or pharmaceutical environment.
• Strong understanding of clinical trial methodology, GCP, ICH guidelines, and regulatory requirements.
• Experience in oncology trials is highly preferred, with additional exposure to complex therapeutic areas considered a plus.
• Familiarity with EDC systems, clinical documentation, and electronic data tools.
• Strong organizational skills with the ability to manage multiple sites and priorities independently.
• Excellent communication and interpersonal skills, with the ability to engage effectively with site staff and internal teams.
• Willingness and ability to travel up to 60%, including overnight and occasional international travel.
• High level of professionalism, attention to detail, and ability to work both independently and collaboratively in a team environment.

• Competitive salary range of $91,500 – $137,300 USD depending on experience and qualifications.
• Annual discretionary bonus eligibility.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plans and financial wellness benefits.
• Life insurance and disability coverage.
• Paid parental leave and family support programs.
• Paid time off including vacation and sick leave.
• Exposure to advanced clinical research programs across complex therapeutic areas.
• Travel-related allowances and opportunities for international collaboration (where applicable).