Senior Clinical Research Associate - Remote Position

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

Summary/Objective

The CRA/SCRA is responsible for acting as a central point of communication between Puma and investigators for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect.

Essential Functions

Conduct on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, and site close-out

Conduct other site visits, as requested

Participate in site selection process; perform evaluation of site capability and make recommendation for inclusion/exclusion in clinical trial

Facilitate preparation and collection of site level documents

Oversee site recruitment, implementing appropriate contingency plans, as needed

Assess site performance and conduct training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations (including study milestones)

Maintain communication with sites between visits to resolve issues, support the staff, oversee the efficient conduct of the trial, and ensure continued compliance

Write confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs

Oversee site's data query resolution

Oversee inventory, maintenance and accountability of investigational product on site

Conduct training in the electronic data capture application and processes, as necessary

May assume responsibilities of local (or global) CRA Lead, as instructed by the Director/designee

Prepare regulatory submissions when required

Assist with budget negotiations under the direction of the Director/designee, if assigned

Perform other tasks, as assigned by the Director/designee to promote the efficient conduct of the trial

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Education & Professional Experience

Required:

Bachelor's degree or equivalent combination of education/experience, preferably in science or health-related field

Minimum of 5 years of clinical trial experience in pharmaceutical/biotech company or

CRO

Minimum of 2 years of CRA field monitoring experience

Strong understanding of GCP, ICH, and knowledge of regulatory requirements

Preferred:

Oncology experience

Global trial experience

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel

Position is a mix of remote and on-site monitoring. Out-of-area and overnight travel is expected, currently less than 50%. However, travel requirements are expected to increase in the future, up to 75%.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds.

Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Compensation Range

The base compensation range for this position is $145k - $160k per year, higher compensation may be available for someone with advanced skills and/or experience.

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