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Clinical Research Psychologist (PhD/PsyD)

Employer
Parexel - USA
Location
Glendale, United States
Salary
Competitive
Start date
25 Sep 2022
Closing date
18 Oct 2022

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Discipline
Healthcare, Pharmacy
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Position Description
• Full Time, Monday - Friday; daytime hours. On Call every third weekend is required.
• Can maintain clinical hours outside of this position.

Key Accountabilities
• Execute all appropriate Investigator responsibilities on assigned projects.
• Serve as a Primary and Sub-Investigator on research protocols.
• Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure efficient and compliant clinical operation.
• Assist with the psychological and clinical oversight of all aspects of function and work performed.
• Assist with training and input on performance assessments for clinical operations personnel.
• Work directly with clinical operations personnel in diagnostic assessment of trial subjects, psychiatric histories, and evaluation of inclusion/exclusion criteria for study participants.
• Participate in on-call and general psychiatric coverage schedules.
• Liaise with sponsors on study conduct and study progression as requested.
• Provide psychological consultation as required or requested by the client/sponsor or the clinical staff.
• Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency.
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
• Establish working relationships with client representatives, promoting confidence and reliability regarding the clinical operations.
• Represent California Clinical Trials Medical to clients in a positive and professional manner.
• Provide support for marketing activities as requested.
• Liaise with physician staff of Glendale Adventist, Brotman MC and local/regional medical consultants as necessary.
• Participate in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies.
• Participate in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness.
• Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed.
• Ensure that all established timelines relating to areas of responsibility and assigned projects are met.
• Ensure that the quality standard of clinical work product is met.
• Perform other duties as assigned by immediate supervisor.

Skills
• Excellent interpersonal skills.
• Detailed oriented with the ability to work in a fast paced environment.

Education
• Ph.D or PsyD required

Minimum Work Experience
• Clinical practice experience of at least two years is preferred.
• Clinical or pharmaceutical research experience desirable.
• Ability to obtain and maintain an unrestricted license to practice psychological services in the state of California.
• Knowledge of the FDA regulated drug development process is helpful.
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