Experienced Clinical Research Associate at Medpace, Inc. New York, NY
Behavioral Health Market Context
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Benefits
Paid Time OffHealth Insurance
Job Description
plore the research field 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:
• Nurses
• Dieticians
• Pharmacy Technicians
• 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 P rofessionals A chieving C RA E xcellence:
• 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
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 sites 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 :
• Minimum of a bachelors degree; Health or life science related field preferred;
• Willing to travel approximately 20% nationally;
• Familiarity with Microsoft Office; and
• Strong communication and presentation skills a plus.
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? :
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
Awards
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
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:
• Nurses
• Dieticians
• Pharmacy Technicians
• 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 P rofessionals A chieving C RA E xcellence:
• 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
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 sites 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 :
• Minimum of a bachelors degree; Health or life science related field preferred;
• Willing to travel approximately 20% nationally;
• Familiarity with Microsoft Office; and
• Strong communication and presentation skills a plus.
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? :
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
Awards
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Qualifications
- •No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs
- •Expansive experience in multiple therapeutic areas
- •Work within a team of therapeutic and regulatory experts
- •Willing to travel approximately 20% nationally;
- •Familiarity with Microsoft Office; and
- •Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
Benefits
- •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
- •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
- •Dynamic working environment, with varying responsibilities day-to day
- •Defined CRA promotion and growth ladder with potential for mentoring and management advancements
- •Competitive pay and opportunity for significant travel bonus
- •Hybrid work-from-home options (dependent upon position and level)
- •Competitive PTO packages
- •Company-sponsored employee appreciation events
- •Employee health and wellness initiatives
- •Flexible work schedule
- •Competitive compensation and benefits package
- •Structured career paths with opportunities for professional growth
Responsibilities
- •Dieticians
- •Health and Wellness Coordinators
- •PACE MEDPACE CRA TRAINING PROGRAM
- •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
- •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 sites 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
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