Clinical Research Coordinator II - Psychiatry

DM CLINICAL RESEARCH GROUP•Houston, TX

6d•Onsite

About The Position

The Clinical Research Coordinator II in Psychiatry 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 working to meet or exceed study enrollment expectations. The role involves coordinating study activities and participant visits, maintaining regulatory and study documentation, supporting recruitment and retention, and collaborating with research participants, investigators, internal teams, sponsors, and CRO representatives. The coordinator also conducts informed-consent discussions and helps ensure participants understand study procedures, risks, benefits, and alternatives.

Requirements

High school diploma or equivalent required.
At least 2 years of experience as a Clinical Research Coordinator; experience coordinating industry-sponsored studies in a private setting is preferred.
At least 1 year of experience as a Clinical Research Coordinator in psychiatry and behavioral health.
Familiarity with clinical assessment tools, psychometric testing, and psychiatric rating scales, including distributing, collecting, and reviewing patient-reported scales such as EQ-5D, GAD-7, PHQ-9, QID-SR, CSFQ-SF-14, SDS, and WPAI:D.
Experience administering cognitive and performance batteries such as the Cogstate Battery, DSST, and MMSE.
Experience administering safety scales such as C-SSRS, AIMS, BARS, SAS, and the Simpson-Angus Rating Scale.
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 in Psychology, Neuroscience, Biology, Public Health, Nursing, or a related health science discipline, or foreign medical graduate status with psychiatry experience.
ACRP or equivalent certification.
Bilingual English/Spanish verbal and written communication and comprehension skills.
Experience coordinating industry-sponsored studies in a private setting.

Responsibilities

Complete required company training, including ICH-GCP and IATA certifications, and complete study-specific training before study start and on time thereafter.
Conduct study subject visits and protocol-required procedures, documenting them promptly.
Maintain clinical trial documentation in accordance with ALCOA-C standards.
Complete data entry and resolve queries in a timely manner according to company guidelines and sponsor expectations.
Follow up promptly on site action items.
Implement laboratory manuals and protocol-specified laboratory procedures, including storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team.
Coordinate with laboratory and data teams, administrative staff, clinical investigators, research participants, and sponsor/CRO representatives as directed by the Site/Study Management Team.
Adhere to assigned protocols and maintain working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and study protocols.
Maintain knowledge of recruitment and retention processes for assigned protocols and work toward sponsor enrollment goals.
Prepare for sponsor and CRO visits and remain familiar with current study protocols, informed consents, manuals, and other study documents.
Oversee reporting of adverse events, serious adverse events, and other safety information to appropriate authorities according to 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, explain study protocols and medical procedures, and ensure participant comprehension before obtaining consent.
Facilitate communication among patients, healthcare providers, and research staff.
Perform other duties as assigned by management.