Job Description

Position: Senior Clinical Research Associate (Senior CRA) 

Department: Clinical Operation 

Location: USA   

Leader: Dr. Dmitry (CPD) 

  • Job Summary 

We are seeking a highly skilled and experienced Senior Clinical Research Associate (Senior CRA) to join our dynamic team. This role will be based in the United States and will focus on clinical research projects within the field of medical devices. 

If you meet the above requirements we welcome you to join our team. If you are interested, please submit your resume and cover letter to [Dennis.Dai@mdcecro.com]. We look forward to welcoming you on board! 

Responsibilities

  • Conduct site initiation, monitoring, and close-out visits to ensure the successful execution of clinical trials. 

  • Develop and maintain strong relationships with investigative sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. 

  • Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Data Management, to ensure the timely and successful completion of clinical trials. 

  • Perform site qualification and initiation activities, including investigator meetings, to ensure the selection of qualified sites. 

  • Monitor study progress and address any issues or deviations from the protocol promptly. 

  • Prepare and review essential study documentation, including informed consent forms, case report forms, and monitoring plans. 

  • Participate in the development and review of clinical study protocols and contribute to the preparation of regulatory submissions. 

Qualifications

  • Bachelor's degree in a relevant field; advanced degree preferred. 
  • Minimum of 8 years of experience as a Clinical Research Associate in the medical device industry. 
  • Strong knowledge of GCP, FDA regulations, and international regulatory requirements. 
  • Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. 
  • Proven ability to manage multiple priorities and meet deadlines in a fast-paced and dynamic work environment. 
  • Willingness to travel domestically as needed for site visits.