Premier Research is looking for a Clinical Research Associate II / SCRA to join our Clinical Monitoring, Site Management and SSU team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
ROLE RESPONSIBILITIES:
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
Maintains submission of expenses according to travel and expense requirements within company guidelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
Plans day-to-day activities for monitoring a clinical study and sets priorities per site
Prepares for and conducts on-site or remote qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
Monitors with knowledge of quality/scope/timeline and budget parameters
Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member
Manages query resolution process with sites and Premier Research Data Management
Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Maintains an understanding of the required essential documents according to ICH/GCP Appendix C. Reviews site documents and verifies they are accurate, complete, current, and include required updates
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Assists project team with assessing project feasibility and recruitment, as applicable
Maintains project tracking system of subjects and site information, as applicable
Participates in Investigators’ Meeting as designated by the Project Manager
Maintains communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts
Attends meetings as required
Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
Completes timely entry of hours worked and project codes per time entry guidelines
Maintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clients
Acquire basic knowledge of disease or condition under study. Participates in available training offered to increase therapeutic knowledge
Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
Maintains proper, timely communication with study teams and management, as needed
Completes all required internal training (general and study-specific) on-time
Identifies confidential information and complies with global and local laws and guidelines
In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
Acts as a resource for other CRAs and shares knowledge base and best practices
Performs other activities as designated
REQUIREMENTS:
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
2+ years’ experience in clinical trials and proven previous success as a CRA; previous clinical research experience required, completion of CRA training program
Read, write and speak fluent English; fluent in host country language
Experience in coaching/mentoring other CRAs
Global experience preferred
Knowledge of ICH / GCP regulations
Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Knowledge of web-based communication tools for conferences and any other IT systems required for the job
Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out
Full-time availability to internal and external project team members
Excellent team player, collaborative and able to enable an effective team
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, able to meet deadlines
Self-starter with a lot of common sense and able to act on own initiative
Accountable, dependable and strong commitment
Applies clear and consistent performance standards and handles problems decisively and objectively
Customer service focused in approach to work, both internally and externally
Maintains a positive, results orientated work environment