Clinical Research Associate Entry
Melbourne | careers.medpace.com |
Job Summary :
What can Medpace offer you?
• Full-time employment and office-based
• 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 transportation allowance
• Annual Merit increases
• Variable Compensation Bonus Plan – Lucrative bonus calculated directly from the number of visits you do
• MEDPACE CRA TRAINING PROGRAM (PACE®)
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.
• No metric for minimum required days on site per month.
• Airline club allowance
• Casual Dress Code
Responsibilities :
• Conduct 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;
• 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; 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 :
• Bachelor's degree in a health or science related field;
• Prior 1 year of study coordinator experience is preferred;
• Willing to travel approximately 60-80% to locations nationwide is required, or less if remote/virtual visits;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.
Medpace 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.
Why Medpace? :
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT.
The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks (vary by location and position):
• On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon
Awards:
• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
What can Medpace offer you?
• Full-time employment and office-based
• 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 transportation allowance
• Annual Merit increases
• Variable Compensation Bonus Plan – Lucrative bonus calculated directly from the number of visits you do
• MEDPACE CRA TRAINING PROGRAM (PACE®)
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.
• No metric for minimum required days on site per month.
• Airline club allowance
• Casual Dress Code
Responsibilities :
• Conduct 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;
• 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; 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 :
• Bachelor's degree in a health or science related field;
• Prior 1 year of study coordinator experience is preferred;
• Willing to travel approximately 60-80% to locations nationwide is required, or less if remote/virtual visits;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.
Medpace 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.
Why Medpace? :
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT.
The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks (vary by location and position):
• On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon
Awards:
• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
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