Clinical Research Associate (CRA) Manager

Employer
Samumed
Location
San Diego, CA
Posted
Sep 18, 2018
Required Education
Bachelors Degree
Position Type
Full time

Open Position

Clinical Research Associate (CRA) Manager

Location

San Diego, CA

About

Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, Alzheimer’s disease, androgenetic alopecia, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.

Job Description and Responsibilities:

Samumed is looking to add a highly motivated Clinical Research Associate (CRA) Manager to its Clinical Development team. The CRA Manager is responsible for the training, development, and assignment of the Company’s CRAs in order to ensure qualified monitoring resources are delegated to the Company’s ongoing clinical studies. This position is a full-time position in the Company’s San Diego headquarters. The CRA Manager’s responsibilities include:     

  • Supervising and mentoring CRAs across all therapeutic areas and protocols
  • Assisting CRAs in following monitor plan under risk-based and traditional monitoring models
  • Collaborating with Clinical Development team regarding CRA resourcing, including forecasting of monitoring requirements and work scope
  • Supervising quality and performance of monitoring activities
  • Conducting performance assessment visits and identifying training needs and development opportunities
  • Addressing training needs and authorizing training materials
  • Performing other study lead duties as necessary

Requirements:

  • 4 year life sciences or health care related degree
  • Minimum 3 years of experience in a CRA management role
  • Minimum 2 years of clinical monitoring experience
  • Proficient in MS Office software
  • Excellent verbal and written communication skills
  • Travel required in connection with co-monitoring activities