The Clinical Research Associate position at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with medical and/or health/life science interest and background who want to explore the research field, 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!
Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include: •Dieticians •Pharmacists •Pharmaceutical/Device Sales Representatives •Biotech Engineers •PhD/Pharm.D candidates •Health and Wellness Coordinators •Research Assistants.
PACE - MEDPACE CRA TRAINING PROGRAM No research experience is needed as 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.
Unexpected Rewards This role takes you on a journey through travel and excitement which 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
DESCRIPTION OF JOB DUTIES As a CRA, you will specifically be responsible for the following: •Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol; •Communication with the medical site staff including coordinators, clinical research physicians and their site staff; •Verifying 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; •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; •Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement; •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/REQUIREMENTS: •Must have a minimum of a university degree in a health or life science related field, •Approximately 60-80% travel; •Proficient knowledge of Microsoft® Office and general computer literacy; •Outstanding communication and Presentation skills; •Must be detail-oriented and efficient in time management; •Excellent verbal and written communication skills in English and German; •Previous experience as a CRA and /or other related clinical research environment is a plus, as well as •Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
AWARDS Medpace is being recognized locally, nationally, and globally for their work in the industry as well as the culture they have developed for their team. •Medpace Named a Top Cincinnati Workplace for 2015 by the Cincinnati Enquirer •Medpace named Top Ten CRO in 2015 CenterWatch Investigative Site Survey •Medpace once again is nominated for the Eagle Award in 2015 - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships. (Medpace previous Eagle Award award winner two years running)
WHAT TO EXPECT NEXT We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.