Experienced Clinical Research Associate

2-4 years

Not Disclosed

Navi Mumbai

15 June 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary

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 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

Home-based option available for CRA for more than 1 year of monitoring experience.

Responsibilities

As a CRA, you will specifically be responsible for the following:

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;
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

Bachelor's degree with at least 2 to 4 years of experience as a Clinical Research Associate;
Willing to travel approximately 60-80% 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?

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.

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