Sr. CRA

SR. CRA

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client is focused on the research and commercial development of engineered DNA-binding proteins for the regulation of gene expression and for gene modification and is seeking to add a Sr. CRA to their team in Richmond, CA.

 

RESPONSIBILITIES:

- Assist in the design, planning and implementation of clinical research projects, including drafting project plans and timelines as needed

- Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets

- Negotiate and finalize site contracts and budgets, manage and calculate site payments

- Perform site visits including site qualification, initiation, monitoring and close-out visits

- Hire, train and supervise regional monitors and review monitoring reports

- Ensure sites comply with study protocol (to ensure accurate and complete data collection) and federal regulations

- Represent in a professional manner; establish and maintain good relationships with investigators and study site personnel

- Maintain frequent site contact; and prepare, track, and manage required study documentation and supplies

- Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents)

- Review data listings on an ongoing basis

- Determine and oversee site drug requirements and accountability and other supply requirements

- Plan and coordinate Investigator Meetings

- Assist in preparing interim study analyses, annual reports, and clinical study reports

- Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)

- Reviews draft statistical reports for accuracy and consistency

- Manage overall study budget

- Mentor and train junior Clinical Research Associates

 

QUALIFICATIONS:

- 5 to 7 years of experience in planning and overseeing clinical trials for a biotech company

- Demonstrated ability to independently supervise a clinical trial from initiation to close in accordance with regulations and with company policies and procedures

- Thorough knowledge of GCP, ICH and FDA regulations

- Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast paced environment

- Self-motivated, assertive and able to function independently or as part of a team

- Strong written and verbal communication; strong interpersonal skills

- Ability to travel 30-40%

 

EDUCATION:

- BA/BS degree in a nursing, pharmacy, life sciences or health-related discipline

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.