Clinical Research Associate, Sponsor Dedicated

Eligibility

To be eligible for this position, you must reside in the same country where the job is located.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close‑out) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to protocol conduct and regulatory adherence; escalate quality issues as appropriate.
• Manage progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution; may support start‑up phase.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow‑up letters, and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, support development of project subject recruitment plans on a per‑site basis.
• If applicable, manage site financials according to the executed clinical trial agreement and retrieve invoices according to local requirements.

Qualifications

• Bachelor’s degree in a scientific discipline or health care preferred; equivalent combination of education, training, and experience may be accepted.
• At least 2 years of on‑site monitoring experience.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Therapeutic and protocol knowledge as provided in company training.
• Proficiency with Microsoft Word, Excel, PowerPoint, and use of a laptop, iPhone, and iPad (where applicable).
• Strong written and verbal communication skills with good command of English.
• Organizational, problem‑solving, time‑management, and financial‑management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Pay

The potential base pay range for this role, when annualized, is $71,900.00 – $189,000.00. Actual base pay may vary based on qualifications, location, and schedule (full‑ or part‑time). Incentive plans, bonuses, and other forms of compensation may also be offered, along with a range of health, welfare, and other benefits.