Experienced Study Start Up Associate (Home-Based/Remote)

3-4 years

Not Disclosed

Remote

10 Feb. 12, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Title: Experienced Study Start-Up Associate (Home-Based/Remote)
Location: Chile
Department: Site Activation & Maintenance
Job ID: 10543

Job Summary:

Medpace is seeking an Experienced Study Start-Up Associate to join its team in Chile. This is a remote or home-based role, ideal for someone looking to gain valuable experience in regulatory submissions and clinical research. As a Regulatory Submissions Coordinator, you will receive mentorship and support to enhance your skills while contributing to the success of clinical trials.

Responsibilities:

Project Support: Assist in day-to-day departmental/project activities, such as collecting vital documents for ethics submissions and preparing study documents for submission to competent authorities.
Compliance: Help ensure deadlines are adhered to and assist Regulatory Submission Managers and Start-Up teams in ensuring compliance with applicable regulations and requirements.
Quality Control: Conduct quality control of submission documents.
Reporting: Maintain spreadsheets and compile reports.
Guidance: Provide advice and guidance to internal and external team members regarding regulatory requirements.
Additional Tasks: Perform other related tasks as required.

Qualifications:

Education: Bachelor’s degree in Life Sciences (or a related field) is required.
Experience: 3–4 years of regulatory submissions experience.
Skills:
- Strong organizational and prioritization skills.
- Proficiency in Microsoft Office.
- Exceptional attention to detail and excellent written and oral communication skills.
Language: Fluency in spoken and written English is required. Please submit applications in English.

Medpace Overview:

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With more than 5,000 employees across 40+ countries, Medpace is committed to accelerating the global development of safe and effective medical therapeutics. Medpace operates with local regulatory and therapeutic expertise in key therapeutic areas, including oncology, cardiology, metabolic diseases, and more.

Why Medpace?

Global Impact: The work Medpace does positively impacts patients and families facing a wide range of diseases.
Career Development: Medpace offers structured career paths, mentorship, and the opportunity to work on impactful projects.
International Exposure: Gain exposure to a wide array of therapeutic areas and develop professionally in the clinical research field.

This position offers a great opportunity to work remotely, gaining hands-on experience in regulatory submissions and clinical research while contributing to the success of clinical trials. If you're looking to grow your career in this field, apply today!

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Experienced Study Start Up Associate (Home-Based/Remote)

Job Description

Job Summary:

Responsibilities:

Qualifications:

Medpace Overview:

Why Medpace?

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