HiRO - Harvest Integrated Research Organization

Harvest Integrated Research Organization (HiRO) is a global, boutique Clinical Research Organization (CRO) that streamlines and accelerates cross-border clinical trial pathways for pharmaceutical and biotech companies. They offer tailored partnership solutions across all stages of clinical development, from discovery to patients. HiRO's services include project management, regulatory affairs and strategy, clinical science and medical affairs, clinical operations, data science, and quality and audit. The company emphasizes efficiency driven by experience, leveraging big data & AI, and pioneering R&D solutions. With a team that collectively has over 15 years of experience and 100% of staff with oncology & immunology project experience, HiRO aims to bridge the gap between laboratory research and market commercialization, facilitating scientific breakthroughs to reach patients globally.

BiotechClinical TrialsCROData ScienceGlobalPharmaceuticalProject ManagementRegulatory Affairsharvestiro.com

HiRO - Harvest Integrated Research Organization

BiotechClinical TrialsCROData ScienceGlobalPharmaceuticalProject ManagementRegulatory Affairsharvestiro.com

HQSomerset, US

Team Size97

Open Jobs18

Total Funding$2M

Latest Fundraise4 years ago

Join the Team

Clinical Research Associate Ⅱ/SCRA

On-SiteSeoul, KR

On-Site • Seoul, KR

Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.

Job Title: Clinical Research Associate II/Senior Clinical Research Associate

Location: 5F, 460, Bongeunsa-ro, Gangnam-gu, Seoul, Republic of Korea

Job Summary: The CRA will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.

Key Responsibilities:

Qualifications:

Minimum of 3 years of independent monitoring experience.
Excellent oral and written communication skills in English, including proficient presentation skills required.
Oncology monitoring experience strongly preferred.
Excellent communication, collaboration, and problem-solving skills.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Demonstrate good computer skills and be able to embrace new technologies.
Ability to manage required travel of up to 75% on a regular basis including by air, driving, etc.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.

What We Offer:

A dynamic and innovative workplace that embraces new ideas.
Compensation package & shall be commensurate with experience.
Supportive colleagues that are driven by their passion for our mission.
Opportunities for accelerated career advancement as the team grows.
We offer a comprehensive benefits package .

If you are interested in this role, please apply. We also encourage you to follow our company page on Linkedin for the most up to date company news and job postings.

At HiRO, we believe that curiosity drives innovation, hard work fuels success, and creativity inspires solutions. We’re looking for individuals who thrive on exploring new ideas and approaches. If you are passionate about your work and eager to contribute to a collaborative and inclusive environment, we want to hear from you.

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Performs on-site site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and protocol compliance.

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

Assesses site processes.

Conducts Source Document Review of appropriate site source documents and medical records.

Verifies required clinical data entered in the case report form (CRF) is accurate and complete.

Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

Verifies site compliance with electronic data capture requirements.

Perform investigational product (IP) inventory, reconciliation and reviews storage and security.

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan.

Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Must be able to quickly adapt to changing priorities to achieve goals / targets.

Prepares for and attends Investigator Meetings and/or sponsor in person meetings.

Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.