Senior Clinical Research Cover Letter

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

Previously, I was responsible for compliance guidance on the conduct of clinical research, risk management, and/or clinical evaluation division-wide, for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization.

Please consider my qualifications and experience:

• Experience with cancer clinical trials and working knowledge of working with a sensitive, cancer patient population
• Experience with Oncore and Apex
• Experience with gastrointestinal (GI) oncology protocols
• Experience working with GI oncology patient population
• Experience with training others in oncology clinical trials coordination
• Active New York State Registered Nurse or Physician Assistant license
• Knowledge of scientific methodology and associated medical terminology
• Experience in clinical research federally sponsored projects, recruiting subjects and managing multiple ongoing studies

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

Previously, I was responsible for technical and administrative support to clinical research projects that conduct regulated and nonregulated clinical trials.

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

• Experience with SharePoint software
• Experience designing web sites and computer-based surveys
• Prior experience with data abstraction and data entry
• Bachelor's of Science (BS)
• Demonstrated knowledge and application of protocol development and study design for ophthalmic medical device studies is preferred
• Working knowledge of Good Clinical Practices, global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals
• Project management experience and proficiency with related tools (Microsoft Project)
• HS graduation and sufficient clinical research experience and demonstrated skills to successfully perform the assigned duties and responsibilities

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

Previously, I was responsible for leadership in the development of efficient and effective processes to improve the conduct of clinical research across all clinical departments.

Please consider my qualifications and experience:

• Working knowledge of HIPAA and Committee on Human Research Guidelines
• Understand statistical methods as applied to Bio-Medical Research
• Certification by the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP)
• Understand the process of Evidence Based Medicine
• Knowledgeable in vascular disease, preferably venous disease
• Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive)
• Scientific/clinical knowledge needed to adequately monitor the trial
• Strong scientific background with deep understanding of infectious disease and oncology molecular diagnostic areas

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

Previously, I was responsible for coordination of various clinical research projects, including both behavioral and clinical management trials.

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

• Certificate of Completion of HIPPA training
• Certificate of completion of CITI training
• Knowledge of Code of Federal Regulations and Good Clinical Practice as it relates to spine surgery clinical trials Experience with medical record abstraction, data collection
• Sensitive to HIPAA confidentiality rules
• Excellent PC computer skills including Internet, MS Word, Excel and SPSS
• Provide leadership for staff
• Knowledge of policies and procedures regarding Committee on Human Research (CHR)
• Experience working with spine surgery patients

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

Previously, I was responsible for day-to-day management of an assigned portfolio of clinical research studies and clinical trials.

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

• Basic leadership presence
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
• Experience with managing clinical data in a research setting
• Experience training, mentoring, and/or supervising others on topics related to clinical research conduct and management
• Specialty training or extensive experience in human nutrition science and research methodology related to pediatrics, neonatology, gastroenterology, immunology, allergy, and/or maternal/adult nutrition highly desirable
• Experience planning, executing, and managing global clinical trials