Experienced Clinical Research Associate (Home-Based, anywhere in Norway)

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Responsibilities:

* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating  protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications:

* Clinical Research Associate Experience (minimum 18 months of independent monitoring);
* Ability to travel 60-70% to locations nationwide is required;
* Must have a minimum of a bachelor's degree in a health or science related field;
* Proficient knowledge of Microsoft(r) Office;
* Fluency in local language and excellent English;
* Must be detail-oriented and efficient in time management.
			

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