Job Description
CON Clinical Research Associate
Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit . We have an excellent opportunity for a Contract/Temporary Clinical Research Associate to join our San Diego team
This position will be based out of the San Diego, CA. office with minimum two days a week on-site Minimal travel may be expected based on potential co-monitoring requests or meetings attendance from the Sponsor Position Summary: On a contract basis responsible for supporting the clinical operations aspects of the study team, interfacing with cross-functional team members, external vendors (CRO) and as required, investigator trial sites) to monitor conduct and progress of clinical research studies. In-house position (not a monitor).
Primary Responsibilities: - Performs, in collaboration with TMF Operations group, ongoing reviews of the study eTMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines
- Completes tasks across multiple clinical trial studies, ensuring that the safety of the subjects and the integrity and validity of the study data are maintained as needed
- Reviews regulatory documentation to support study start-up activities, including ensuring required study drug and clinical supplies are available on site for site initiation visits and maintains the same during the life cycle of assigned trials
- Acts as liaison for assigned study sites, CROs and external vendors (including central laboratories) to convey study-related information, answer questions and resolve issues in accordance with an agreed upon escalation pathway
- May attend Investigator Meetings to relay study information, provide updates and answer questions for assigned trials
- Attends study-specific training for assigned trials
- Reviews all phases of study monitoring reports (PSV, SIV, IMV, and COV)
- In this position, experience with role of an unblinded CRA, required.
- Oversees subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites to update detailed tracking sheets daily
- May co-monitor sites as required
- Independently prepares and maintains various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, Investigator Brochure, etc.) and follows up to collect outstanding documents
- Prepares meeting agenda, minutes and follows up on action items as needed
- Reviews key study documents (i.e. Protocol, Schedule of Assessments, Informed Consent Form, Study Plans, Pharmacy Manual, Laboratory Manual, etc.)
- Performs all duties in compliance with all applicable Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines
- Adheres to all department and company-wide policies regarding conduct, performance and procedures
- Performs other duties as required
Education/Experience/Skills: Position minimally requires a high school diploma/GED with at least 7 years of related experience; a Bachelor's degree with at least 3 years' experience is preferred. Experience with role of an unblinded CRA required. At least 2 years of direct experience with investigator site management, CRO/Vendor management and logistical execution of clinical trials is required. Prior experience working in a biotech or pharmaceutical industry required. Experience with Outlook, Excel, PowerPoint and Veeva eTMF required. Experience with SmartSheet and SharePoint preferred.
Position also requires : - Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Understanding of clinical trials, drug development, Phase I through Phase III
- Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint
- Solid working knowledge of ICH GCP as it relates to clinical trial management
Physical, Mental and Environment Demands: The physical, mental and working environment 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 the duties
of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Specific mental demands for the position are listed above under requirements. In addition, mental demands for this position include:
- Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
- Ability to work and sustain attention with distractions and/or interruptions.
- Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
- Ability to maintain regular attendance and be punctual.
- Ability to understand, remember and follow verbal and written instructions.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Expected Base Salary Range: $51.00/hr. - $60.00/hr.
The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience.
Americans with Disabilities Act (ADA) Statement The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact [click to reveal email address] HR@xencor.com .
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Equal Employment Opportunity (EEO) Statement The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.
Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.
Job Tags
Full time, Contract work, Temporary work, Work at office, Remote work, 2 days per week,