Under the direction of the Director Clinical Research, 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. Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Responsible for compliance with Institutional Review Board (IRB) and Good Clinical Practice (GCP) guidelines and all related laws, regulations, policies, and guidelines. Ensures availability of appropriate resources throughout the clinical research enterprise, with a focus on study implementation and management. Manages physical and human resources, with an emphasis on compliance with research regulations.
Valleywise Health is committed to providing high-quality, comprehensive benefits designed to help our employees and their families stay physically and financially fit. Known for the diversity of not only the community of patients we serve but also our workforce and the benefits we offer, such as:
- Medical, Dental, and Vision Plans
- Flexible Spending Accounts
- 100% Retirement Match in the Arizona State Retirement System (ASRS)
- Paid Time Off and Paid Holidays
- Sick and Extended Illness Bank
- Tuition Reimbursement Programs
- And much more
Annual Salary Range: $93,496 - $137,904
JOB QUALIFICATIONS
Education or equivalency:
- Requires a Bachelor’s Degree in a clinical research or related technical 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 a 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 a 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:
Certification/licensure:
- Requires SoCRA certification as a Certified Clinical Research Professional (CCRP) ; or ACRP/APCR certification as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), CRC or Certified Principal Investigator (PI).
- Requires Basic Life Support (BLS) certificate issued by the American Heart Association.
Knowledge, Skills, and Abilities:
- Must have knowledge of the principles, methods, and procedures of basic medical and/or clinical research.
- Requires Must have excellent communication skills (interpersonal, written, verbal), skill in the use of personal computers and related software applications.
- Requires Must have 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 Must have advanced knowledge of medical research coordination, administration, and fiscal control principles and procedures.
- Must have skills in organizing resources and establishing priorities.
- Must have the ability to develop, plan, and implement short- and long-range goals; and provide technical leadership and direction to staff members.
- Requires Must have knowledge of scientific experimental design and protocol development procedures.
- Must have sScientific 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 Must have knowledge of Good Clinical Practice (GPC)GCP guidelines and Occupational Safety and Health Administration (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.
