Clinical Research Associate II/Sr. CRA

HiRO - Harvest Integrated Research Organization; North Carolina; Remote; USD 58,000 - 98,000; Full time

Job summary

HiRO is seeking a Clinical Research Associate II/Senior Clinical Research Associate to oversee Phase I-IV clinical research projects. The role involves site management, ensuring compliance with protocols and regulations, and requires strong communication and problem-solving skills. This remote position includes travel and offers opportunities for career advancement within a dynamic team.

Benefits

Comprehensive benefits package

Paid time off

Medical/dental/vision insurance

401(k) plan

Qualifications

• Minimum of 2 years of independent monitoring experience.
• Oncology monitoring experience strongly preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines.

Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Verify informed consent processes and clinical data accuracy.
• Manage site-level activities to meet project objectives.

Skills

Excellent communication

Collaboration

Problem-solving

Education

Bachelor’s degree or RN in a related field

Job description

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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: US, Home based

Work Type: Remote, with frequent travel

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:

• 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.

Qualifications:

• Minimum of 2 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 including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

We are committed to providing equal employment opportunities for all. HiRO does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.

Contact us:

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.

This role is not open to agency soliciation.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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