Entry-Level Clinical Research Associate - Clinical Study Coordinator

Job Title: Entry-Level Clinical Research Associate (remote) - Clinical Study Coordinator

Job Location: UNAVAILABLE, UNAVAILABLE, Austria

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: The Clinical Research Associate role at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development. For those with a Life Sciencedegree with clinical research experience who want to travel throughout Germany, Austria, Switzerland and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

PACE – MEDPACE CRA TRAINING PROGRAM

Medpace provides comprehensive initial and ongoing training, unmatched by other CROs.

Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence:

PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.

PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.

• To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

REWARDSThis role will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including:

• Dynamic working environment, with varying responsibilities day-to day;

• Expansive experience in multiple therapeutic areas;

• Work within a team of therapeutic and regulatory experts;

• Defined CRA promotion and growth ladder with potential for mentoring and management advancements;

• Competitive pay and opportunity for significant travel bonus.

CRA PERKS:

• Flexible work hours across days within a week

• In-house travel agents

• Ongoing therapeutic training by our in-house physicians, who are medical and regulatory experts

• Opportunities to work with international team of CRAs

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.

Quali...