Job Description

Key Responsibilities

• Support study start-up activities, including supply inventory, document preparation, and site initiation readiness.
• Assist with participant screening workflows as delegated, including scheduling screening visits and collecting basic information such as demographics, medical history, and other study-relevant details to support eligibility assessment.
• Schedule and prepare for participant visits, including source prep, lab kits, and CRFs.
• Serve as a participant liaison—confirm appointments, coordinate transportation, and maintain ongoing communication.
• Escort and assist participants during on-site visits; perform vital signs, ECGs, and specimen collection/processing as trained.
• Complete accurate, ALCOA+-compliant source documentation for delegated procedures.
• Perform data entry into EDC systems and assist with query resolution.
• Maintain study binders, charts, and logs; support supply management.
• Ensure accurate capture and upload of paper source documents into eSource systems in accordance with site processes and regulatory requirements, supporting long-term retention and audit readiness.
• Obtain, track, and manage medical releases, as well as medical and pharmacy records from external providers as needed, in accordance with site SOPs and protocol requirements.
• Support CRCs during monitoring visits and assist with preparing documentation and materials to ensure audit and inspection readiness.
• Assist with investigational product (IP) accountability tasks as needed and where applicable, gaining exposure to IP handling, tracking, and documentation under the direct supervision of CRC staff, while ensuring adherence to protocol and site SOPs.
• Develop proficiency in site SOPs, institutional policies, and GCP requirements to build foundational knowledge in compliant research practices.
• Assist in collecting and entering study data into trackers, logs, and EDC systems, focusing on accurate and timely data collection.
• Support CRCs in maintaining accurate records and updating study metrics.

Required Skills

(MUST LIVE in Bronx)

• Strong attention to detail, organization, and communication skills.
• Proficiency in Microsoft Office.
• Willingness to perform phlebotomy and clinical procedures as trained.

Preferred Skills

• Minimum requirement of a high school diploma or GED equivalent; Bachelor’s degree preferred.

Schedule/Shift

Full Time On Site

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