Support the study lead(s) in day-to-day operational management of one or more clinical trials.
Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements.
May manage one or more key study vendors including central lab, IRT/RTSM, or CRO.
Monitor and track study progress, patient recruitment, and data collection at investigational sites.
Review and verify the accuracy, completeness, and quality of clinical trial data.
Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files.
Collaborate with investigators, study coordinators, and other site staff to provide guidance and support.
Identify and escalate any issues or deviations from the study plan to the appropriate parties.
Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions.
Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.

Requirements

Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience.
2+ years of clinical operations experience or related drug development.
Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
Excellent organizational and time-management skills.
Strong communication and interpersonal skills.
Ability to work independently and as part of a cross-functional team.
Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems.
Willingness to travel to investigational sites as required.
Familiarity with early phase clinical trial protocols and procedures a plus.
Prior vendor management experience a plus.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical operationsdata collectionregulatory compliancevendor managementclinical trial documentationcase report formsGood Clinical Practice (GCP)ICH guidelinesclinical researchdrug development

Soft Skills

organizational skillstime-management skillscommunication skillsinterpersonal skillsindependent workteam collaborationproblem-solving skillsguidance and support