Senior Clinical Research Scientist

US-MD-Rockville
# Positions
1
Years Experience
6+
Category
Current Opening

Overview

KAI Research is currently seeking a Sr. Clinical Research Scientist (CRS) to join KAI’s Clinical Research Department. This position will report to the President of KAI Research, and will support the Medical and Clinical Research Directors, and other Clinical Development colleagues in the delivery of company objectives.  The CRS will also partner with the clinical operations team to ensure study delivery. So join our team and help make a difference in the lives of millions of people! This position will be responsible for the provision of scientific and clinical research expertise to achieve quality and efficiency throughout the clinical study process. 

Responsibilities

  • Provides review, analysis, and categorization of clinical studies, and grants for clients.
  • Lead, direct or provide general oversight, monitoring, and quality assurance for planned and ongoing projects/studies.
  • Provides technical or subject matter expertise in clinical research regulations and policies.
  • Coordinates and manages the development of general and study specific guidelines.
  • Develops, designs and implements clinical trial protocols, informed consent forms and CRFs for Phase I-IV clinical trials, and interfaces with principal investigators.
  • Confer with biostatistician to assess and makes recommendations to clients on statistical issues including statistical analysis plan, randomization scheme, safety monitoring and reporting characteristics for client sponsored clinical trials.
  • Provides leadership and participates in writing and editing of proposals, clinical study reports, and draft presentations and manuscripts.
  • Serves as liaison with outside medical and scientific experts; interacts with company clients; participate as technical expert for strategic or marketing decisions.
  • Advise on best practices for DMCs/DSMBs.
  • Provides technical and subject matter expertise for compliance and audit services.

Qualifications

  • PhD or MD/PhD in Health Sciences.
  • Certification in Clinical Research (CCRA, CCRI, RAC) preferred.
  • Six to ten years’ experience in the drug or device development process and Phase I-IV clinical trials that includes, but not limited to study design, budget development and management, clinical research project management with multi-site trials, data analysis, regulatory requirements and scientific writing.
  • Supervisory experience.
  • Experience in interactions with FDA, regulatory agencies and the medical/scientific community.
  • Excellent written and verbal communication skills, with medical writing experience preferred.
  • Ability to work independently and work with a matrix team environment required.
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies.
  • Must be able to work on multiple projects simultaneously.
  • Ability to build and maintain good working relationships with a diverse array of clients.
  • 0-10% travel requirement for this position.
  • General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.

 About KAI Research, Inc.

 

KAI Research, Inc., an Altarum company, is a full-service contract research organization (CRO) and health research company. Since 1986, we’ve helped pharmaceutical, academic, and federal clients accelerate time to market for innovative drug treatments and other interventions. We have supported several federal clients for multiple decades and coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas.

 

Using a collaborative, “high touch” approach, we offer a wide range of clinical research services, including study management, observational studies and registries, patient recruitment and site partnerships, regulatory affairs, data management and eClinical solutions, monitoring, safety and pharmacovigilance, statistical support, and quality assurance. Our decades of experience allow us to predict needs, avoid common barriers, and move from a quick startup through each research phase.

 

KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

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