Clinical Research Coordinator II

Job Title:

Clinical Research Coordinator IIJob Description

The Clinical Research Coordinator II (CRC II) plays a crucial role in providing research services to patients participating in clinical trials. This role involves overseeing, planning, tracking, and ensuring that clinical activities for study participants are conducted according to approved protocols. The CRC II collaborates within a multidisciplinary environment, maintaining professionalism and effective communication with both internal and external colleagues. This position includes direct patient contact and managing the clinical and operational aspects of moderately to highly complex study protocols.

Responsibilities

+ Serve as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols.

+ Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration.

+ Contribute to study feasibility reviews and make recommendations based on protocol analysis and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes.

+ Ensure adherence to study protocols, maintain accurate documentation, and meet regulatory and protocol requirements and guidelines per ICH/GCP, federal regulation, and institutional and sponsor requirements.

+ Identify instances of noncompliance and deviations from protocol and report them to the appropriate parties.

+ Advise the Principal Investigator through updates on protocol issues, status of signatures, and clinical significance on lab reports, ECGs, adverse events, and other documents as required.

+ Analyze, document, and convey study data. Collaborate with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.

+ Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations.

+ Assess trial execution program-wide, identify areas needing improvement or correction, and provide education and/or recommendations.

+ Collaborate with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensure implementation and adherence to stated plans.

+ Collaborate with the Quality Education Unit to contribute to the design of CRC trainings and continuing education.

+ Participate in interim monitoring visits, internal audits, and external audits/inspections.

+ Oversee the work and advise on protocol management and recruitment to CRC I development.

+ Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies.

+ Perform other duties as assigned.

Essential Skills

+ Strong professionalism, judgment, and ability to handle confidential information.

+ Knowledge of clinical research terminology and regulatory requirements, including GCP, FDA regulations, and HIPAA.

+ Self-directed with the ability to manage multiple studies independently.

+ Advanced interpersonal and communication skills, both written and oral.

+ Ability to manage multiple tasks in a fast-paced environment with strong attention to detail.

+ Bachelor's degree in a health-related discipline, or other related field and two years of clinical research experience.

+ Minimum of one year of experience in clinical trials coordination.

+ Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required.

Additional

Skills & Qualifications

+ Knowledge of clinical trial management systems and experience with electronic medical records (EMR).

+ Oncology experience is preferred.

+ Bachelor's degree in a scientific, health-related, or business administration field preferred; advanced research training is a plus.

+ Demonstrated experience in clinical trials coordination.

+ Certification from ACRP/SOCRA or equivalent is preferred.

Work Environment

The position requires working five days per week on-site with the ability to work one day remotely, depending on patient demand. The work environment offers the opportunity to support cutting-edge research while ensuring compliance with complex billing and regulatory standards, directly impacting patient care and clinical trial integrity. This role involves partnering with cross-functional stakeholders across research, finance, and compliance, gaining exposure to high-impact operations within a world-renowned academic medical center.

The environment provides a…