Clinical Research Coordinator II

DM CLINICAL RESEARCH GROUP•Indianapolis, IN

12d

About The Position

The Clinical Research Coordinator II ensures quality research at assigned investigative sites in accordance with sponsor protocols, FDA regulations, and ICH/GCP guidelines, while providing high-quality data to sponsors and meeting or exceeding study enrollment expectations. The role supports timely achievement of company goals through study coordination, participant visits, documentation, data entry, safety reporting, and communication with site and sponsor teams. The coordinator completes required organizational and study-specific training; conducts protocol-required visits and procedures; maintains accurate clinical trial records; and supports laboratory procedures and study operations under the direction of the Site/Study Management Team. The role also supports recruitment and retention, prepares for sponsor and CRO visits, communicates with research participants and healthcare teams, and facilitates informed consent discussions so participants understand study procedures, risks, benefits, and alternatives. Other duties may be assigned by management.

Requirements

High school diploma or equivalent required.
At least 2 years of experience as a Clinical Research Coordinator.
Detail-oriented, energetic, able to multitask, and goals-driven while maintaining quality.
Proficient verbal and written communication and comprehension skills in English.

Nice To Haves

Bachelor's degree preferred.
Foreign Medical Graduates preferred.
Experience coordinating industry-sponsored vaccine studies, preferably in a private setting.
ACRP or equivalent certification preferred.
Proficient verbal and written communication and comprehension skills in both English and Spanish preferred.

Responsibilities

Complete required company training, including ICH-GCP and IATA certifications, and complete relevant study training before study start and on an ongoing basis.
Conduct study subject visits and protocol-required procedures, documenting them in a timely manner.
Maintain clinical trial documentation in accordance with ALCOA-C standards.
Complete data entry and resolve queries promptly according to company guidelines and sponsor expectations.
Follow up on site action items in a timely manner.
Implement laboratory manual and protocol-specific procedures, including specimen storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under Site/Study Management Team direction.
Coordinate with laboratory and data teams, administrative staff, clinical investigators, research participants, and sponsor/CRO representatives.
Maintain compliance with assigned protocols and working knowledge of applicable FDA regulations, ICH-GCP guidelines, company SOPs, guidance documents, and study protocols.
Support recruitment and retention processes and work toward sponsor enrollment goals for assigned protocols.
Prepare for sponsor and CRO visits and maintain current versions of protocols, informed consents, manuals, and other study documents.
Oversee reporting of adverse events, serious adverse events, and other safety information to appropriate authorities in accordance with company guidelines, sponsor requirements, IRB requirements, and ICH-GCP guidelines.
Attend required company meetings and submit administrative paperwork within company timelines.
Occasionally attend out-of-town Investigator Meetings.
Conduct patient consent discussions and ensure participants understand medical procedures, risks, benefits, and alternatives before consent is obtained.
Explain study protocols clearly and facilitate communication among patients, healthcare providers, and research staff.
Perform other duties as assigned by management.