Experienced Clinical Research Associate (Positions Available For All Locations In India)

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?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve 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 Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility