Clinical Research Coordinator II

Summary:

The Clinical Research Coordinator II (CRC II) supports daily clinical research operations under the direction and ongoing supervision of the Site Manager, Site Director, and Principal Investigator, in accordance with required protocols. The CRC II is responsible for coordinating and managing clinical trials designed to test the effectiveness of new drugs or biotechnology across Phases I-IV.

Essential Duties and Responsibilities:

• Communicate effectively and courteously with study participants regarding study objectives and ongoing instructions.
• Administer questionnaires and monitor participant compliance.
• Acknowledge study patients' needs and tend to them appropriately.
• Collect participant medical history and medical conditions.
• Obtain informed consent in accordance with regulatory and protocol requirements.
• Maintain study drug dispensation and accountability records.
• Coordinate with laboratories to ensure timely participant testing.
• Collect and review concomitant medication information.
• Collect and review medical records for protocol and regulatory compliance.
• Conduct adverse event (AE) and serious adverse event (SAE) assessments.
• Perform EKGs, vital signs, nasal swabs, and protocol-specific procedures.
• Manage and oversee clinical laboratory reports.
• Maintain site regulatory files in accordance with SOPs and regulations.
• Verify the accuracy and completeness of data collected.
• Assist with the recruitment and engagement of study participants as needed.
• Document temperatures for investigational product (IP) stored on-site.
• Develop study eSource documents in compliance with study protocols.
• Manage and lead multiple clinical trials across different therapeutic areas.
• Manage all required study start-up documentation, training, and timelines for assigned protocols.
• Meet all study protocol requirements and deadlines.
• Manage and adhere to approved study budgets.
• Participate in and support interim monitoring visits (IMVs) and site initiation visits.
• Support sponsor audits and regulatory inspections.
• Perform Quality Control (QC) and compliance reviews within study trials.
• Adhere to site SOPs, Good Clinical Practice (GCP), and regulatory requirements.
• Strictly adhere to confidentiality and compliance standards.
• Perform other duties as assigned.

Qualifications:

• Associate's degree in healthcare or related field preferred.
• Minimum of 4 years of experience in Clinical Research and knowledge of protocols and procedures required.
• Minimum of 4 years of experience in FDA regulations and GCP.
• Minimum of 2 years of experience in phlebotomy and EKGs required.
• Proven track record of analytical reasoning skills.
• Exceptional attention to detail and organizational skills.
• Must possess excellent verbal and written communication skills.
• Excellent customer service skills with internal and external stakeholders.
• A proven ability to multitask in a rapidly changing environment.

Certificates, Licenses, and Registrations:

• CPR certification required.
• Maintain IATA certification and any other required job-related certifications.
• Good Clinical Practice (GCP) certification required.
• Current, active certification as a Medical Assistant required.

ACN does not provide visa sponsorship for this role. Candidates who will require immigration or visa sponsorship at any time now or in the future (including, but not limited to, H-1B, TN, or STEM OPT training plans) are not eligible for this role.

About the Company:

At Alliance Clinical Network, our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health.