Senior / Clinical Research Associate Cover Letter

I am excited to be applying for the position of senior / clinical research associate. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for clinical Research Support by working closely with the Clinical Director (CD), Clinical Deputy Director (CDD) and Clinical Operations Manager (COM) of the NIDCR (National Institute of Dental and Craniofacial Research) Division of Intramural Research (DIR), Office of the Clinical Director (OCD) to provide oversight and management of the clinical research program supported by the Institute.

Please consider my experience and qualifications for this position:

• Have a full understanding of Serious Adverse Event (SAE)
• Participate in the development of protocols and Case Report
• Ideally have been in all stages of clinical research monitoring experience
• Experienced in Cardiovascular or Endocrinology studies area
• Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms)
• Knowledge of good clinical trial design and basic understanding of statistics
• Remain current on clinical trial regulatory requirements and guidelines
• Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious disease

In response to your job posting for senior / clinical research associate, I am including this letter and my resume for your review.

In the previous role, I was responsible for evidence based clinical care to outpatients within the Integrated Brain Health Clinical and Research Program and/or participants in clinical research trials, individuals or group, in person or via video.

My experience is an excellent fit for the list of requirements in this job:

• Previous hands-on experience in clinical research at either a pharmaceutical/biotech company or hospital
• Frequently drives to site locations
• Extensive knowledge of GCP/ICH Guidelines and other applicable regulatory requirements
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus
• Superb understanding of all aspects of clinical research
• Basic personal computer skills including a working familiarity with word processing software and relevant clinical applications
• A general familiarity with cardiac, vascular, and/or neuromodulation technologies
• Fluency in English and in the country's native lanugage

I submit this application to express my sincere interest in the senior / clinical research associate position.

Previously, I was responsible for clinical guidance and insight for Research Operations team; including Case Report Form (CRF) development, clinical data quality control (QC), and clinical research to support projects.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience with CE and/or US-IVD regulatory submissions
• Hands-on experience with companion diagnostics (CDx), genomics and/or proteomics assay development is highly preferred
• Bachelor of Science (B.S.) or Master of Science (M.S.)
• Minimum 2 yrs of CRA experience
• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Switzerland
• Fluency in speaking and writing German/French/Italian and English
• Fluency in oral and written Dutch and English
• Current driver’s license essential

I submit this application to express my sincere interest in the senior / clinical research associate position.

In the previous role, I was responsible for guidance, coaching and management of the product and technology’s clinical leadership team including Clinical Solutions, Clinical Analytics, and Clinical Research.

Please consider my experience and qualifications for this position:

• Experience in the field of immunology/neurology is an advantage co-monitoring or regional monitoring
• Good understanding of current International Council on Harmonisation - Good Clinical Practice (ICH-CGP) and local requirements of clinical research and able to create strong internal & external relationships to drive positive team-spirit
• Come with a “can-do-attitude” and a structured problem solving mindset
• Preferably has experience in clinical study monitoring or coordination
• Competent in written and oral English and Spanish
• Able to interpret clinical data, meet deadlines and work effectively with
• Certification as a Research Professional by Society of Clinical Research
• In Vitro Diagnostic (IVD) products experience in molecular diagnostics or immunodiagnostics

In response to your job posting for senior / clinical research associate, I am including this letter and my resume for your review.

In the previous role, I was responsible for oversight to all clinical trials in the research clinic to include program reporting and is the primary contact for sponsor clinical audits.

Please consider my qualifications and experience:

• Pharmacovigilance and benefit/risk management industry and/or Big 4 pharma consulting experience specializing in strategy design/development and change management/communications
• Knowledge/experience of Strategic Planning/Business Improvement frameworks
• Demonstrated knowledge, experience and best practices with key multi-channel, global change management, learning and development and training frameworks, tools, platforms and processes
• Demonstrated experience in delivering and measuring business outcomes from executing multi-channel strategies and investments
• Experience supporting change management initiatives in a highly matrixed and complex environment
• Requires frequent travel to sites
• Knowledge of ICH/GCP Guidelines and other applicable regulatory requirements
• BA/BS or higher in life or health sciences preferred