Clinical Research Coordinator II: Study Trials Lead

DM Clinical Research; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

DM Clinical Research invites a Clinical Research Coordinator II to join our Indianapolis site. You will ensure quality data collection, adherence to sponsor protocols, and timely enrollment while maintaining FDA, ICH-GCP, and internal SOP standards.

Training in ICH-GCP and IATA is emphasized, with ongoing education to support study activities. The role requires coordinating visits, managing lab procedures, and communicating across teams to meet sponsor expectations and preserve data integrity.

Qualifications

• Minimum of 2 years' experience as a CRC, preferably coordinating vaccine trials.
• Strong English communication, both written and verbal; bilingual in English/Spanish preferred.
• Proficient in data entry, query resolution, and regulatory document management.
• Knowledge of FDA regulations, ICH-GCP, and study protocols.

Responsibilities

• Coordinate subject visits and ensure adherence to protocol requirements.
• Maintain ALCOA-C quality and accurate study documentation.
• Conduct data entry and resolve sponsor/site queries promptly.
• Monitor safety information and report adverse events per guidelines.
• Communicate with investigators, staff, and sponsors to support enrollment.

Skills

Attention to detail

Multitasking

English communication

Bilingual English/Spanish

Education

HS Diploma or equivalent

Bachelor's degree preferred

ACRP certification preferred

Job description

DM Clinical Research invites a Clinical Research Coordinator II to join our Indianapolis site. You will ensure quality data collection, adherence to sponsor protocols, and timely enrollment while maintaining FDA, ICH-GCP, and internal SOP standards.

Training in ICH-GCP and IATA is emphasized, with ongoing education to support study activities. The role requires coordinating visits, managing lab procedures, and communicating across teams to meet sponsor expectations and preserve data integrity.