"Clinical Research Coordinator 2"

Overview

The Clinical Research Coordinator II (CRC II) is responsible for providing research services to patients participating in clinical trials. Key responsibilities include overseeing, planning, tracking, and ensuring clinical activities for study participants are conducted in accordance with approved protocols. These activities include patient screening, eligibility determination, registration, and other protocol milestones. The position works within a multidisciplinary environment, collaborating with internal and external colleagues to ensure professionalism and effective communication. The CRC II will have direct patient contact and manage the clinical and operational aspects of moderately to highly complex study protocols.

Required Skills and Abilities

1. Strong professionalism, judgment, and ability to handle confidential information.
2. Knowledge of clinical research terminology and regulatory requirements, including GCP, FDA regulations, and HIPAA.
3. Self-directed with the ability to manage multiple studies independently.
4. Advanced interpersonal and communication skills, both written and oral.
5. Ability to manage multiple tasks in a fast-paced environment with strong attention to detail.

Preferred Skills and Abilities

1. Knowledge of clinical trial management systems and experience with electronic medical records (EMR).
2. Oncology experience preferred.
3. Bachelor's degree in a scientific, health-related, or business administration field preferred; advanced research training is a plus.
4. Demonstrated experience in clinical trials coordination.
5. Certification from ACRP/SOCRA or equivalent is preferred.

Principal Responsibilities

1. Serves as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols.
2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration.
3. Contributes to study feasibility reviews and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes.
4. Ensures study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements.
5. Identifies instances of noncompliance and deviations from protocol and reports and advises noncompliance and deviations to the appropriate parties.
6. Advises Principal Investigator through updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.
7. Analyses, documents and conveys study data. Collaborates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.
8. Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations.
9. Assesses trial execution program wide and identifies areas that need improvement or that require correction and provides education and/or recommendations, as needed.
10. Collaborates with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans in the preparation of corrective action plans and ensures implementation and adherence to stated plan.
11. Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education
12. Participates in interim monitoring visits, internal audits, and external audits/inspections.
13. Oversees the work and advises on protocol management and recruitment to CRC I development.
14. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies.
15. Performs other duties as assigned.

Required Education and Experience

Bachelor’s degree in a health-related discipline, or other related field and two (2) years of clinical research experience, or the equivalent combination of education or experience. Minimum of one (1) year experience in clinical trials coordination. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required. Experience must indicate the ability to work with minimal supervision in a team environment.