Manager Clinical Research

Facility: Valleywise Health Medical Center

Department: Research Administration

Schedule: Regular FT 40 Hours Per Week

Shifts: Days

Under the direction of the Chief Medical Officer, this position is responsible for the successful execution of clinical trials and academic studies from the protocol concept through the clinical study report, ensuring completion of study deliverables and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Responsible for compliance with Institutional Review Board (IRB) / Human Research Review Committee requirements, the Good Clinical Practice (GCP) guidelines and all related laws, regulations, policies, and guidelines.

Qualifications

Education:

• Requires a Bachelor's degree in Nursing, Academics or related field, or an equivalent combination of training and progressively responsible experience that will result in the required specialized knowledge and abilities to perform the assigned work.
• A Master's degree in related field is preferred and may substitute for two (2) years of required experience.
  
  

Experience

• Must have a minimum of five (5) years of progressively responsible clinical trial and/or academic research experience in Pharmaceutical, Biotech or CRO company or Academic Research Institution that includes conducting, managing, monitoring, analyzing or reporting on clinical and academic research.
• Experience must also include either direct or indirect supervisory related duties.
  
  

Specialized Training

• None
  
  

Certification/Licensure

• Requires SoCRA certification as Certified Clinical Research Professional, or ACRP/APCR certification as a CRA, CRC or PI, or must possess a current valid AZ RN license, temporary AZ RN license, or valid compact RN licensure for current state of practice and be in good standing with the issuing Board of Nursing.
• Requires BLS. A BLS card obtained through an approved American Heart Association (AHA) training center is preferred.
  
  

Knowledge, Skills & Abilities

• Must have knowledge of the principles, methods, and procedures of basic medical and/or clinical research.
• Requires excellent communication skills (interpersonal, written, verbal) skill in the use of personal computers and related software applications.
• Requires the ability to analyze and interpret data and prepare evaluative summary reports and correspondences.
• Must have excellent organizational and time management skills with strong attention to detail and prioritizing.
• Requires advanced knowledge of medical research coordination, administration, and fiscal control principles and procedures.
• Must have skills in organizing resources and establishing priorities.
• Must have ability to develop, plan, and implement short- and long-range goals; and provide technical leadership and direction to staff members.
• Requires knowledge of scientific experimental design and protocol development procedures.
• Scientific data management skills, using advanced computerized data analysis techniques is preferred.
• Must be skilled in examining and evaluating operations and developing and/or re-engineering operating strategies, systems, and procedures.
• Must have ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments, and employee development and performance management skills.
• Requires knowledge of Good Clinical Practice (GPC) guidelines and OSHA standards; human and/or animal research policies, regulations, procedures, and standards, as applied to IRB and compliance operations; and building and leading project teams, ideally in a cross functional capacity.
• Requires the ability to read, write and speak effectively in English.
  
  

Salary Range: Hourly rate: $44.95 - $66.30