CRC II

Clinical Research Coordinator II

About:

The Clinical Research Coordinator II (CRC II) is the backbone of our clinical research operations, overseeing the
day-to-day execution of multiple complex trials across various therapeutic areas and research phases. You'll ensure
efficient study implementation and administration while adhering to protocols and regulations. Responsibilities span
end-to-end clinical trial execution, including participant recruitment, screening, and eligibility determination in collaboration
with the Principal Investigator (PI). As the primary point of contact for participants, sponsors, and regulatory agencies,
you'll provide clear communication and maintain accurate documentation. Additionally, you'll play a leadership role by
assisting and mentoring other clinical team members.

Responsibilities:

Manage Research Operations:

• In partnership with PIs, guide participants through the informed consent process and conduct ongoing visits, procedures, and assessments.
• Provide comprehensive project management for assigned trials from start to finish.
• Safeguard patient well-being by enforcing regulatory and protocol adherence throughout the study lifecycle.
• Manage communications with study sponsors, CROs, vendors, and PIs.

Recruit & Enroll Study Participants:

• Identify and enroll qualified participants for ongoing and new clinical trials, through collaboration with PIs, use of study portals, and other tools.
• Manage all aspects: feasibility assessment, IRB submissions, data collection, quality assurance audits, and regulatory compliance.
• Oversee study materials, supplies, and communication across study teams.

Champion Data Quality & Processes:

• Manage the clinical trial management system (CTMS) for various tasks including: new study builds, participant screening/recruitment, medical record review, AE tracking/reporting, regulatory document preparation, source document maintenance, study visit scheduling, and more.
• Oversee accurate and timely data entry into electronic data capture (EDC) systems, including those managed by the trial sponsors, CROs, and internal clinical trial management systems (CTMS).
• Collaborate with PIs and other team members to ensure data quality through independent monitoring and adherence to SOPs, GCP, and regulations.
• Maintain accurate participant logs and manage study-related expenses.
• Archive records according to Macro SOPs.

Become a Clinical Research Expert:

• Master study protocols through in-depth review and collaboration with PIs.
• Support new site startup, study qualification and activation, equipment procurement & installation, and ensure all aspects of trial infrastructure are in place.
• Provide support to colleagues by providing back-up support, training new members, and improving research processes. Uphold the highest standards of confidentiality, attendance, and punctuality.

Qualifications:

• BA or BS in health-related field
• Bilingual in Spanish and English
• Minimum of 3+ years of experience in a research role with an institution involved in conducting industry-sponsored, interventional clinical trials for investigational drugs