Clinical Research Assistant

Rovia Clinical Research•Bastrop, LA

About The Position

The Clinical Research Assistant assists with the execution of new studies and the maintenance of open and closed studies, performing administrative and clinical tasks for trials. This position works in close collaboration with Clinical Research Coordinators, other Research Assistants, sponsors, and compliance to carry out responsibilities per the study protocol.

Requirements

Sound knowledge of medical terminology.
Sound knowledge of ICH/GCP and Regulatory requirements.
Knowledge of Good Clinical Practice (GCP) and FDA and HIPAA policies and practices.
Excellent interpersonal skills to work effectively with colleagues, clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
Strong organizational skills.
Proficient in the use of Microsoft Office and Excel.
Fluent in spoken and written English language.
Ability to work independently, prioritize actively, seek input, solve problems, and work in a team environment.
Meticulous attention to detail.
Ability to maintain confidentiality.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
High school diploma required.
Phlebotomy or Medical Assistant certification or experience, as required by county authorities to perform clinical tasks.

Nice To Haves

Clinical research experience preferred.
Current GCP and IATA certification preferred or must be obtained upon hire.

Responsibilities

Assists the Principal Investigator (PI) and other research staff to ensure clinical research and related activities are performed in accordance with federal regulation and Rovia SOPs.
Performs clinical tasks like lab processing, phlebotomy, diagnostic tests, drug accountability, and vital signs, where appropriate and as delegated by the PI, in accordance with local requirements and licensures.
Maintains the documentation of appropriate and necessary training for research staff on the study-specific training log.
Cooperates with Rovia compliance and monitoring efforts, reporting instances of noncompliance to the Rovia Clinical Operations and Compliance departments.
Attends and participates in investigator meetings, monitoring visits, audits, seminars, and other regional or national meetings as required.
Collects study documents needed to initiate the study and submit to the sponsor.
Organizes and maintains filing in all study documentation, including regulatory binders, study-specific source documentation, and other materials.
Develops a working familiar with study protocol, including study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Supports site documentation, including but not limited to submission of data into the Electronic Data Capture system, source documentation, case report forms, Dear Doctor letters, and consent forms.
Schedules study participant appointments and serves as the patient liaison to the PI and other investigators, which may include performing study visit reminder phone calls and registering subjects to the appropriate coordinating center.
Maintains adequate inventory of study supplies and follows the sponsor protocol and Rovia SOPs on Investigational Product Accountability.
Registers subject visits in the Rovia Clinical Trial Management System in a timely manner to ensure appropriate billing of study procedures.
May perform other job-related duties as requested or required.