Clinical Research Associate/Site Manager

We are seeking a skilled and motivated Clinical Research Associate with specialized experience in major depressive disorder (MDD) to join our dynamic research team. As a key member of our organization, you will play a crucial role in the planning, execution, and monitoring of clinical trials related to major depressive disorder. Your expertise in MDD will contribute to advancing our understanding of treatment options and improving the lives of individuals affected by this condition.

Responsibilities

• Prepares for and conducts site qualification and site initiation, visits. May also include interim and closeout monitoring visits.
• Schedules clinical site visits as required by clinical monitoring plans.
• Main point of contact between assigned sites, Medical Science Liaison and Sponsor

·Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements.

• Tracks and reports all site visit-related expenses in accordance with the company travel & expense guidelines.
• Delivers high quality and timely reports following each site management or site monitoring visit.
• Works with the Lead CRA to identify, escalate, and resolve issues at assigned clinical sites.

·May include maintaining Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites.

May include managing query resolution process with clinical sites and data management groups.

Qualifications

·Bachelor of Science in related field required, Master's Degree is preferred

·3+ years of clinical monitoring or site management experience.

·Prior experience with CNS (Major Depressive Disorder) trials strongly preferred.

·Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.

·Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate high quality and timely work.

·Must be able to work effectively within a team environment (independently and collaboratively).

·Excellent written and verbal communication skills including strong professional presentation skills (internal and external audiences).

·Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements.

·Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).

Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines