Regional CRA in San Jose, CA at Apex Life Sciences

Date Posted: 7/9/2018

Job Snapshot

Job Description


Regional CRA



The Clinical Research Associate is responsible for tasks that relate to the monitoring and management of clinical trials. Regionally based associates work out of their home office providing monitoring of clinical trials, assuring adherence to Good Clinical Practice. This position may consistently involve up to 65% travel. Clinical Research Associates may be involved in some or all of the tasks listed below.

ESSENTIAL DUTIES
•Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out.
•Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
•Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
•Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
•Monitoring and documenting laboratory sample storage and shipment.
•Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities.
•Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
•Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
•Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
•Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present.
•Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
•Other tasks or responsibilities as assigned.

The Employee shall work well under pressure, and meet multiple and sometimes competing deadlines. The Employee shall at all times demonstrate cooperative behavior with colleagues and supervisors.

OTHER QUALIFICATIONS
•Attention to detail.
•Flexibility with changing priorities.
•Excellent organizational skills.
•Ability to efficiently perform and prioritize multiple tasks.
•Ability to identify and take initiative to solve logistical problems.
•Effective verbal and written communication skills.
•Ability to work effectively both independently and on a diverse team.
•Familiarity with medical and pharmaceutical industry, and related terminology and practices.
•Appropriate knowledge of FDA regulations and their practical implementation.
•General computer skills (PC based) with proficiency in Microsoft Word, Excel, and Outlook.
•Ability to work efficiently on the computer, including document retrieval, review, and tracking.

•Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
•Must have a valid driver's license, a good driving record, and up-to-date car insurance.

EDUCATION AND/OR EXPERIENCE
•Nursing registration or licensure and/or 4-year degree, preferably in a scientific or health care discipline, or equivalent combination of education, clinical research certification, and/or experience.
•At least 3 years of prior experience as a Clinical Research Associate , including monitoring experience or high level understanding and proficiency in GCP and monitoring.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.