Senior Clinical Research Associate - Remote Position

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

Primary Objective of Position

The Senior Clinical Research Associate (Sr. CRA) is responsible for acting as a central point of communication between Puma and his/her allocated investigative sites for all assigned clinical trial-related activities, to ensure trials are conducted on time and budget while remaining fully compliant with International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines and the standard operating procedures (SOPs) in effect.

Major Duties / Responsibilities

In-House and Field Sr. CRA

• Maintains on-going communication with sites to respond to questions, resolve issues (eg, data queries, study management), support the site staff, oversee the efficient conduct of the trial, and ensure continued compliance

• Facilitates preparation and collection of site level documents

• Assesses site performance and conducts training/re-training when necessary to ensure site compliance with the protocol, applicable regulations, and Puma expectations

• Develops and maintains relationships with clinical site investigators and other site staff

• Assists site staff in maintaining audit/inspection readiness and in responding to any observations made by the auditor/inspector

• Escalates site issues and collaborates with the study team and site staff to resolve issues

• Participates in and contributes to study-specific team meetings

• Performs other tasks, as assigned by the manager/Clinical Operation Lead/designee, to promote the efficient conduct of the study

If Applicable

• Conducts all activities involved in on-site visits consistent with the applicable Clinical Monitoring Plan (CMP), SOPs, and ICH GCP for site qualification, site initiation, interim monitoring, site close-out, and other site visits (eg, booster visits)

• Writes confirmation letters, follow-up letters, and site visit reports that conform to guidelines and timelines as stated in the applicable CMP and SOPs

• Reviews and approves site-specific informed consent forms

• Submits documents to a central Institutional Review Board on behalf of investigative sites

• Reviews site visit reports as well as confirmation and follow-up letters written by field CRAs, and provides timely feedback

• Mentors less-experienced CRAs

• Manages study team meeting in the absence of the Clinical Trial Manager

• Performs additional activities as assigned:

• Assists with budget negotiations under the direction of the Director/designee

• Manages Clinical Operations vendors under the direction of the Director/designee

• Represents Puma at key therapeutic meetings

• Maintains operational expertise to support Clinical Science Liaison personnel

• Conducts strategic negotiations with site staff

Competencies

• Clear and timely communication, both written and verbal

• Ability to handle a moderate to high volume of highly complex tasks within an established timeframe

• Strong organizational skills and ability to prioritize

• Ability to build relationships within the team, across departments, and with external contacts (eg, site staff, vendors)

• Proactively identify and resolve/escalate project-related operational issues

• Ability to work independently on routine assignments, or under supervision on new assignments

• Familiarity with word processing and spreadsheet programs, document management systems, and electronic data capture applications

Supervisory Duties

This position is unlikely to have employee supervisory responsibilities.

Required Education and Professional Experience

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

• Minimum of five years of health-related experience (eg, study coordinator, research lab, pharmaceutical/biotech company, CRO) or equivalent, including minimum of three years of CRA experience

• Strong understanding of ICH GCP and knowledge of FDA regulatory requirements related to clinical research

Preferred Education and Experience

• Oncology experience

• Global trial experience

• Previous field monitoring experience

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of…