Clinical Research Associate

440

Workplace Type: On-site

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

Job Description
OVERVIEW
In collaboration with our client, the Clinical Site Ambassador (CSA) is responsible for the developing and maintaining the relationship with the site. The CSA is the main point of contact for the site and will be responsible for knowing all aspects of the site capabilities and structure; being an expert on their sites. In addition, the CSA will perform all site management and monitoring activities at a clinical site(s). The CSA will ensure clinical studies are performed in accordance with study protocol, standard operating procedures and associated plans, and relevant local and internal regulations, legislation and ICH/GCP guidelines.

• The CSA will serve as the single point of contact for the assigned sites for the lifecycle of the study in addition to developing and maintaining the relationship pre and post the study timelines. This includes, but not limited to feasibility, study-start-up, essential document/TMF maintenance etc., in addition to supporting the site and other internal client functional areas such as Safety/Pharmacovigilance, Regulatory, Clinical Trail Supply, etc.
• The CSA will be assigned clinical monitoring activities in a single country or in several countries ensuring appropriate clinical study conduct.
• The CSA will ensure subject safety and verify diligence in protecting the confidentiality of each subject. The CSA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
• The CSA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
• The CSA will have to anticipate, recognize and resolve issues for the assigned study sites.

Qualifications

• The ideal candidate has a Bachelor’s degree/Registered Nurse is preferred or approximately (5) years monitoring experience. Prefer scientific discipline and multiple therapeutic experiences
• A minimum of 4 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred.
• For countries other than US and Canada, a minimum of 2 years of experience conducting and supporting RA/CA and IRB/EC submissions and regulatory document start-up activities.
• The ability to perform travel up to an average of 80%, depending on project needs
• The candidate must have excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail
• The candidate must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
• This role may be office and/or home-based/field-based however regular infrequent visits to a Company office will also be required.

Minimum Training Requirements: The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:

• Applicable Standard Operating Procedures
• Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local regulations
• 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
• Good Clinical Data Management Practices
• HIPAA – Protected Health Information/GDPR-General Data Protection Regulation, as applicable Drug Development and Regulatory Approval Processes (depending on applicable territory(ies) Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.

Language
You must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated).

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.