Clinical Research Associate II

Responsibilities

Serves as the primary contact for assigned investigational sites and develops effective working relationships with investigators and site staff

Schedules and independently conducts monitoring activities, both on-site and remotely, including pre-study/site qualification, site initiation, interim monitoring, and close-out visits, in accordance with study protocols, Monitoring Plans, Company and/or client SOPs, GCP/ICH guidelines, and applicable regulations

Ensures the rights, safety, and well-being of clinical trial subjects are protected, including verification of informed consent and subject eligibility

Performs source data verification and reviews clinical data for accuracy, completeness, and appropriate documentation; facilitates timely resolution of data queries

Reviews site regulatory files and ensures required essential documentation is complete and maintained throughout the study lifecycle

Performs Investigational Product accountability and verifies appropriate storage, inventory, dispensing, return/destruction, and related documentation

Reviews and supports appropriate reporting and tracking of adverse events and serious adverse events in accordance with regulatory requirements and the Monitoring Plan

Manages assigned sites throughout trial conduct, identifies and resolves site-related issues, and appropriately escalates protocol, SOP, GCP, quality, or compliance concerns

Prepares high-quality monitoring reports and required site correspondence within established timelines

Participates in study meetings, training, investigator meetings, audits, and other project activities as required

May support site and study feasibility assessments, IRB/IEC and regulatory submissions, development of monitoring tools and study documentation, and other study-specific activities

Works collaboratively with Project and Clinical Operations teams to meet project timelines, quality expectations, and study objectives while maintaining confidentiality and compliance with the Company Quality Management System

Benefits

Remote work in the United States

Multi-therapeutic clinical research organization supporting drug development.

Raleigh, North Carolina, USA

https://www.caidya.com

Late Stage

Total Funding

$165M

Key Investors

Rubicon Founders

2025-01-13

Private Equity· $165M

2023-04-17

Series D

Leadership Team

Barbara Kunz

Chief Executive Officer

Michael Clay

Chief Operating Officer

Recent News

Investors in Healthcare

UK: Caidya announces strategic combination with Simbec-Orion

2026-07-01

Business Wire

Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution

2026-06-30

Vivo Capital

Vivo Capital - Portfolio

2026-06-08

Company data provided by

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Qualifications

Four-year college degree, preferably in healthcare, life sciences, or a related field

In lieu of a degree, candidates with two or more years of relevant clinical research experience within the pharmaceutical or CRO industries will be considered

Minimum of one year of experience in on-site monitoring of clinical studies

Demonstrated ability to independently conduct all types of site monitoring visits

Strong written and verbal communication skills

Strong interpersonal skills with the ability to build and maintain effective relationships with investigators, site staff, and study team members

Strong clinical monitoring and documentation skills, with the ability to independently conduct site monitoring visits

Comprehensive knowledge of GCP/ICH guidelines and proficiency in medical terminology

Proficient computer skills, including Microsoft Office

Strong attention to detail, problem-solving, time management, and organizational skills

Ability to exercise sound judgment, work independently, and effectively manage priorities in a matrix environment

Ability to drive an automobile and maintain a valid driver's license, where applicable

In lieu of a degree, candidates with two or more years of relevant clinical research experience within the pharmaceutical or CRO industries will be considered.

Minimum of one year of experience in on-site monitoring of clinical studies.

Required skills

Clinical Trial Monitoring, GCP/ICH Guidelines, Medical Terminology, Microsoft Office

Experience

1+ years