Clinical Research Coordinator

Community Health Systems•Fort Wayne, IN

1d•Onsite

About The Position

The Clinical Research Coordinator functions as part of a multidisciplinary research team to support the compliant implementation and conduct of human subject research studies. This role is responsible for subject recruitment, eligibility determination, informed consent, protocol adherence, data collection, and follow-up for assigned studies. The Clinical Research Coordinator works under the mentorship of the Senior Clinical Research Coordinator and/or Clinical Research, Supervisor and must be detail-oriented, self-directed, and capable of building effective relationships with study participants, sponsors, and internal teams.

Requirements

2-4 years of clinical experience required
2-4 years of clinical research experience required
Knowledge of federal regulations and GCP guidelines governing human subject research.
Excellent organizational, critical thinking, and communication skills.
Ability to manage multiple priorities and deadlines in a fast-paced environment.
Proficient with Microsoft Office Suite and Clinical Trial Management Systems (CTMS).
Demonstrated ability to work independently and collaboratively as part of a research team.
Excellent written and verbal communication skills.
Ability to review detailed data and make prompt judgments based on that data.
Possess critical thinking skills and be capable of decisive judgment.
Meets clinical competency requirements.
Interact effectively and pleasantly with a diverse population.
RN - Registered Nurse - State Licensure and/or Compact State Licensure required
BCLS - Basic Life Support current or obtained within 12 months of employment required
Applicants must be authorized to work in the U.S. for an employer.

Nice To Haves

Bilingual (Spanish) is beneficial.

Responsibilities

Coordinates the implementation and conduct of clinical research studies, ensuring adherence to protocol requirements, reporting of serious adverse events, and timely submission of FDA and sponsor documentation in accordance with Good Clinical Practice (GCP) guidelines.
Performs research-related clinical tasks, including patient screening, informed consent, and clinical assessments within the Registered Nurse scope of practice and under the delegation of the Principal Investigator.
Coordinates care and discharge planning, provides patient education, and conducts follow-up communications.
Administers medications and treatments as ordered by a licensed provider and assists with specialized equipment required by study protocols.
Prioritizes patient care and delegates nursing activities based on patient needs and staff qualifications.
Develops thorough knowledge of assigned study protocols to ensure accurate and compliant execution.
Monitors adherence to protocol, clinical trial agreements, and regulatory requirements from FDA, NIH, and other governing bodies.
Maintains essential regulatory documentation for assigned studies, including CVs, licenses, and laboratory certifications.
Supports entry and management of clinical trial data in the clinical trial management system (CTMS).
Collaborates with study sponsors, contract research organizations (CROs), and internal stakeholders to facilitate site initiation, enrollment, data collection, and close-out activities.
Participates in audit preparation and documentation review, ensuring readiness for monitoring visits and compliance reviews.
Provides records and follow-up support as directed.
Coordinates Human Research Subjects Protection Training for study investigators and supports onboarding for new study staff as needed.
Maintains ongoing communication and professional relationships with patients, families, investigators, and internal departments.
Demonstrates cultural sensitivity and ensures confidentiality in all interactions.
Maintains required training and certifications for research activities, including Human Subjects Protection, GCP, and IATA.
Performs other duties as assigned.
Maintains regular and reliable attendance.
Complies with all policies and standards.