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Posted: Monday, January 8, 2018 1:14 AM


Under minimal supervision, the scope of this position includes facilitating clinical research following strategies and tactics formulated in association with other Clinical Affairs staff to meet department objectives.

Position requires 60% domestic travel

Tasks and responsibilities:

* Provide support for Alere clinical studies:

* Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)

* Support clinical research study start up activities (Includes creation of study binders, study logs, work instructions, case report form, and other study related materials)

* Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution

* Study monitoring (Includes assessing the familiarity of the site personnel with the protocol, procedures and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)

* Timely collection, review, management and filing of all essential clinical documents and communications; including maintenance of site Clinical Central Files (CCF) and reconciling site regulatory binders as appropriate.

* Responsible for understanding CRA II role and responsibilities as stated in this job description, Alere SOPs and WIs, and FDA, ICH and ISO regulations; including understanding study specific roles and responsibilities as outlined in project specific monitoring plans and other project related documentation

* Knowledge and familiarity with the utilization of paper based and electronic data capture systems for the collection of study data

* Familiarity with identifying data discrepancies and writing queries for clarification of data

* Responsilbe for providing quality site management to ensure adherence to study protocol, work instructions and the overall conduct of the study; responsible for identifying, documenting and addressing deviations, facilitating resolutions and ensuring timely study progression

* Responsible for ensuring quality in all clinical research activities including tasks associated with study start up, interim monitoring, close out, data collection and central files

* Demonstrated understanding of the FDA, ICH and ISO regulations for clinical studies including knowledge of how to locate the current regulations and guidance for reference and awareness of all other applicable local regulations that may impact any sites participating in Alere Clinical Studies.

* Requires a minimum of 60% travel in support of clinical study activities. All travel and expenses to be in compliance with Alere company policies.

* Maintain on-going education in the area of clinical trials and research.

* Willingness to provide support for other department duties, projects, and tasks as assigned in an accurate and timely manner.

* Team player able to deliver on project timelines.

* Work involving blood or other potentially infectious materials required.

* Demonstrates commitment to the development, implementation, and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.

* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

* May functionally direct junior staff as required.

* Carries out duties in compliance with established business policies.

* Responsible for exhibiting professional conduct with both internal/external business associates that reflects positively on the department and company, and is consistent with the company's policies and practices.

* Perform other duties & projects as assigned.

Preferred educational background:

BA/BS in Biology, Chemistry or related field.

Position requires 60% domestic travel

Preferred experiential background:

* A minimum of 2 years' experience as a Clinical Research Associate, or an equivalent combination of training and experience in clinical research and or a related field, with particular skills and knowledge of IVD device studies, FDA/ICH regulations and clinical site monitoring.

* Excellent and demonstrated oral and written communications.

* Familiarity with Clinical databases, clinical trials, and medical terminology.

* Familiarity with clinical Case Report Forms, edit checks, query resolution, trouble shooting and resolving data management issues.

* Understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines.

* Demonstrated intermediate level skills with regard to MS Office Suite (including Outlook, Word, Excel, PowerPoint, and Adobe); and a basic knowledge of web based programs and navigation skills.

* The ability to multi-task, work well with others in a team environment, identify priorities, and display time management skills.

* Demonstrated skills in carrying out assignments with minimal guidance in an accurate, effective manner.

* Demonstrated ability to work with a variety of people on multiple tasks.

* Experience mentoring or directing junior staff.

* Ability to work within established timelines, in a fast paced environment.

* Excellent organizational and priority management skills.

* Good interpersonal skills and ability to interact at all levels with sensitivity and tact.

* Demonstrated understanding of database design and development.

* Ability to work with minimal supervision.

* Flexibility in managing shifting timelines and priorities.

* Experienced in managing moderate to high stress environment.

* Experienced business traveler with knowledge of scheduling visits, booking travel and expense reporting.


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• Location: San Diego

• Post ID: 35524297 sandiego is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018