Clinical Research Associate II

Premier Research•Regional_TX, TX

21h

About The Position

Premier Research is seeking a Clinical Research Associate II to join its Clinical Monitoring, Site Management and SSU team. The role supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, devices, and diagnostics, with a focus on protecting patient safety and delivering high-quality clinical data. The CRA works with study teams, clinical leads, data management, and investigator sites to conduct monitoring activities and help keep projects on track. The CRA prepares for and conducts remote and on-site site qualification, study initiation, interim monitoring, and close-out visits as required by the Clinical Monitoring Plan. The role reviews clinical data and site documentation for accuracy, completeness, and compliance with applicable protocols, regulations, and client requirements; manages queries and Trial Master File documentation; communicates with sites and project teams; and supports study feasibility, recruitment, and project tracking as applicable. Travel is 70–85%, and the role may include additional country- or project-specific responsibilities under appropriate guidance or supervision.

Requirements

Undergraduate degree or international equivalent in a clinical, scientific, or health-related field from an accredited institution; licensed health-care professional (for example, registered nurse); or equivalent work experience.
At least 2 years of clinical-trial experience and demonstrated prior success as a CRA; prior clinical research experience is required.
Completion of a CRA training program.
Fluent in reading, writing, and speaking English and fluent in the host-country language.
Experience coaching or mentoring other CRAs.
Knowledge of ICH/GCP regulations.
Working knowledge of FDA Guidance Documents, EU Directives, local regulations, ISO 14155 regulations, drug/device development, and clinical monitoring procedures.
Knowledge of web-based conference communication tools and other IT systems required for the job.
Knowledge of clinical/health systems and cultural and professional practices appropriate to the country or region where monitoring will occur.
Availability to support internal and external project team members full time.
Ability to collaborate and contribute effectively as a team player.
Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Strong verbal and written communication skills.
Excellent organizational and time-management skills and ability to meet deadlines.
Self-starter with sound judgment and initiative.
Accountable, dependable, and strongly committed.
Ability to apply clear and consistent performance standards and handle problems decisively and objectively.
Customer-service-focused approach to internal and external work.
Ability to maintain a positive, results-oriented work environment.
Willingness to travel 70–85%.
Ability to lift up to 25 pounds.
Valid driver’s license and passport as required.

Nice To Haves

Global experience preferred.

Responsibilities

Deliver quality, timely monitoring reports for sponsor approval in accordance with Clinical Monitoring Plan timelines.
Submit expenses in accordance with travel and expense requirements and company guidelines.
Ensure the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites, as required by ICH GCP/ISO 14155, protocols, and client requirements.
Conduct remote, on-site, or other approved monitoring focused on data integrity and patient safety and compliant with country-specific regulations.
Plan day-to-day clinical study monitoring activities and prioritize work by site.
Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits as required by the Clinical Monitoring Plan.
Help move projects forward by reducing and minimizing backlogs.
Monitor within quality, scope, timeline, and budget parameters.
Work with the Clinical Lead or equivalent to proactively manage site visits and trial issues during the monitoring phase.
Monitor clinical deliverable quality, address quality issues with appropriate team members, and escalate issues promptly when needed.
Manage query resolution with sites and Premier Research Data Management.
Maintain the Trial Master File/electronic Trial Master File according to organizational processes and filing guidelines; understand essential document requirements and verify site documents are accurate, complete, current, and updated as required.
Assist the project team with project feasibility and recruitment assessments, as applicable.
Maintain project tracking systems for subjects and site information, as applicable.
Participate in Investigators’ Meetings as designated by the Project Manager.
Communicate with study sites as directed by the Clinical Monitoring Plan and agreed with the sites, and document contacts completely.
Attend required meetings.
Maintain site visit metrics and utilization as required, and alert the line manager to available time as necessary.
Enter hours worked and project codes on time according to time-entry guidelines.
Maintain attention to detail to protect subject safety and ensure quality client data.
Acquire basic knowledge of the disease or condition under study and participate in available training to improve therapeutic knowledge.
Review investigational product accountability and applicable subject- and site-level logs as directed by the Clinical Monitoring Plan.
Maintain timely communication with study teams and management as needed.
Complete required general and study-specific internal training on time.
Identify confidential information and comply with applicable global and local laws and guidelines.
Assume additional country-specific responsibilities when requested, such as start-up, regulatory, site contracts, or office management, with appropriate guidance or functional description documented.
Assume additional project-specific responsibilities when requested, such as clinical management for smaller or less complex studies, under appropriate line-manager or functional-lead supervision.
Serve as a resource for other CRAs and share knowledge and best practices.
Perform other activities as designated.