Clinical Research Associate Cover Letter

I would like to submit my application for the clinical research associate opening. Please accept this letter and the attached resume.

Previously, I was responsible for daily management/supervision to the clinical research staff to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities.

Please consider my experience and qualifications for this position:

• Working knowledge of Good Clinical Practices (GCP) and Human Subjects Protection (HSP)
• Certified Clinical Research Associate (CCRA)
• Understanding how their input and role coordinate more effective business practices for Shire’s Clinical Development business and committment to the culture, vision, and mission of Shire
• Clinical Trials Management Certification
• Understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) regulations, clinical trial monitoring, and regulatory compliance
• General knowledge of Clinical Trial Practices and Regulations
• General knowledge of Clinical monitoring and trial design
• Maintain Clinical Trial Management System (CTMS) for the assigned studies in collaboration with

I would like to submit my application for the clinical research associate opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for clinical trials regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific assigned groups.

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:

• Technical proficiency in rat and mouse dosing by various routes (IV, IP, SC, PO) during the conduct of in vivo studies
• Technical proficiency in necropsy and tissue collection procedures in rats and mice
• Technical proficiency in blood sample collection by various methods in rats and mice as part of the conduct of in vivo studies
• Technical proficiency in measuring subcutaneous tumor growth
• Extensive knowledge and experience in the conduct of mouse and rat pharmacokinetic studies
• Possess a broad-base of skills in support of in vivo biomedical testing, including proficiency in animal dosing and sample collection by various routes and/or methods
• Knowledge of various syngeneic and xenograft tumor models
• Prior experience with specimen processing

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

In the previous role, I was responsible for expertise in the clinical research being conducted, assist with the design, planning and implementation of clinical trials and project activities associated with the monitoring of multi-center clinical studies.

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

• In Vitro Diagnostics (IVD) experience or medical device experience
• Experience with IBM Clinical Development a place
• Work with a dedicated multi-disciplinary research team to coordinate several human genetics and personalized medicine research studies
• Obtain and maintain IRB approval
• Recruit participants, obtain informed consent, and participate in data collection, data analysis, manuscript preparation, and grant preparation
• Provide assistance in ongoing and new genomics initiatives including management of human genetic disease registries, return of participant research results, and assessments of genetic testing implementation
• Have an opportunity to be involved in abstracts, publications, patient education, and other projects
• Working knowledge of database software and basic statistical analysis

I would like to submit my application for the clinical research associate opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for ongoing clinical trial monitoring support to the clinical research physician for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

Please consider my experience and qualifications for this position:

• Demonstrates problem solving skills Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
• Proficient with Sharepoint with filing systems is desirable
• Have prior experience with EDC and an excellent understanding of clinical data flow
• Proficiency in Microsoft Word and Excel, and Clinical Trial Management Systems
• Knowledge of the Australia/ NZ site and regulatory environment is beneficial
• Experience as a research coordinator conducting industry sponsored clinical trials preferred
• Experienced working on multiple oncology clinical trials preferred
• In-depth knowledge of FDA regulations and ICH GCPs

Please consider me for the clinical research associate opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for support to the Clinical Research Supervisor in the oversight of multiple clinical trials.

Please consider my qualifications and experience:

• BA/BS in a Health Sciences discipline
• Medium or above level of English skill
• Bachelor in Biology
• A background as a CRA, ideally within late phase studies but not essential
• Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
• Proficiency with computer/software systems
• Fluency in both written and spoken English and Dutch
• Fluency in French as an added benefit but not essential