Associate Clinical Cover Letter

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

In my previous role, I was responsible for regulatory support for assigned clinical development programs (e.g., INDs, CTAs, clinical components of IMPDs, GCP documentation post-approval documents, etc.).

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:

• Project management and tracking experience is preferred
• Basic understanding of GCP/ICH guidelines is preferred
• Demonstrates experience in working on multiple priorities consecutively and sequentially and meeting quality standard for accuracy, attention to detail and timeliness
• Certified Coding Associate (CCA)
• An understanding of the processes around grant administration and scientific conference organization
• Experience working on complex projects assignments in a matrix environment
• Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO)
• Education and certification as a Clinical Associate/Physician Assistant in accordance with Florida Statue 458

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

In my previous role, I was responsible for training to staff and co-workers in planned clinical studies, GCP and other special knowledge/skills necessary for the conduct of assigned clinical studies.

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

• Prior experience with chart reviews
• Willingness to be trained to take vitals and perform phlebotomy
• Thorough understanding of OASIS documentation and ICD-9 coding
• Flexible and willing/able to work with a variety of teams, physicians and fellow staff members in a team oriented environment to accomplish the research goals of the Oncology- Clinical Trials Support unit (CTSU)
• Driver’s License is a requirement
• Represents the office in a positive, professional manner
• Maintains an up-to-date knowledge of all aspects of the fields of clinical research
• Solid knowledge in CFDA clinical trial regulation and hospital procedures related to GCP

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

In my previous role, I was responsible for advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.

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

• Knowledge of techniques and procedures associated with pediatric care
• Knowledge of clinical trial methodology the drug research and development process
• Knowledge of GCP/ICH Guidelines for clinical studies
• Demonstrates core understanding of medical terminology or clinical trial activities
• Experience in interactions with outside vendors, , CROs and other vendors is preferred
• Experience in global trials preferred
• Solid attention to detail and excellent organization skills
• Solid interpersonal skills and communication skills (both written and oral)

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

Previously, I was responsible for strategic, clinical, and scientific leadership of Phase 0 through Ph2a clinical trials, including mechanistic studies and clinical pharmacology studies.

Please consider my experience and qualifications for this position:

• Experience with e-mail and calendar program
• Sitting, standing and walking for extended period of time
• Basic knowledge of navigation and imaging
• Analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data in order to solve problems or design relatively complex systems and programs that cross departmental/divisional lines
• Experience with product development, including Clinical Evaluation Reports (CER/CRBA), Use Failure Mode Effects Analysis (UFMEA), and pre-clinical protocol development preferred
• Experience in a medical device organization preferred
• Self-starter with a hands on, pragmatic approach and a “can do” attitude
• Experience working in a team-distributed, collaborative environment

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

Previously, I was responsible for input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.

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:

• Basic knowledge of ICH-GCP guidelines and relevant regulations as governs essential documents
• Basic laboratory skills and experience used to process, aliquot and store samples (ex
• Experience with clinical/hospital data systems is preferred
• Experience with IRB process preferred
• Understand clinical trial processes and needs
• IT literacy, particularly in Word, Excel and PowerPoint
• Previous experience of working in Clinical Research or the Pharmaceutical Industry
• Knowledge of the Industry/Clinical trial process, drug development or medical devices