Live chat
Philips Electronics North America

Clinical Research Associate

Philips Electronics North America - San Diego, CA

Clinical Research Associate

in

San Diego

California

Clinical Research Associates (CRA) to participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of cardiovascular and peripheral vascular diagnostic and therapeutic medical devices. CRAs support study activities to meet protocol and corporate objectives, maintaining regulatory compliance and professional integrity for our internal and external stakeholders.

DUTIES AND RESPONSIBILITIES:

Become the study expert and be accountable for driving execution and oversight of all study related activities, including: Managing the study strategy (Investigational Plan), budget, resources, and timelines for assigned clinical trial(s)

Leads the clinical study team in coordinating study activities site screening, initiation, and monitoring visits including preparation and distribution of materials for in-house documentation and site readiness. Ability to train and support site staff and project staff on all aspects of the clinical monitoring and study protocol (investigators, coordinators, Philips staff, vendor staff/contract monitors).

Leads development of site and study documentation such as training materials, reports, consent documents, study operation manuals, monitoring plans and regulatory submissions for the screening, initiation, conduct and reporting of clinical trials.

Leads preparation and maintenance of manuals, forms, tracking tools and reports for AE reporting and medical monitor review.

Leads the clinical study team in clinical data management in CRF development, validation rules and other reporting and analysis tasks, reimbursement for sites.

Supports charter development, reporting and meeting requirements for CEC and DSMB conduct, as well as liaison with committees and members for scheduling and documentation.

Represent Clinical Affairs to key customers

Generates high quality clinical data and status reports to support management, project team, study reports, regulatory submissions and publications.

Coordinates and supports development of clinical study protocols and case report forms with expert input (such as MD, statistical).

Administrates and supports Core Lab activities between sites, Philips and core lab.

Ensuring quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed)

Support development of department SOPs and work instructions, support departmental planning.

Supports investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.

Communicates with team and department members.

Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.

May support project teams for product development.

Support department activities as required

Support corporate strategies in Clinical Affairs

MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:

General knowledge of cardiovascular and/or peripheral vascular disease and therapies

Ability to independently oversee a study team and trial with little supervision

Understands databases, data analysis, and data presentation

Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

Ability to identify customer requirements and manage expectations for clinical studies

Good understanding of biostatistics and trial design

Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

Working knowledge of and ability to follow Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011, and Japanese regulations.

Follows established SOPs and work instructions.

Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support.

Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.

Working auditing and self-auditing skills

Working project management and vendor management skills

General clinical data monitoring skills: paper and EMR

Excellent/advanced oral and written communications skills

Proficient computer skills including word processing, spreadsheet generation and database querying and reporting skills.

Ability to be point of contact for investigators and site staff on a clinical trial.

Demonstrable skills in organizational and project administration skills, tracking study activities for timeliness and completeness.

High attention to detail and accuracy.

Takes ownership and self-motivated

Works effectively on cross-functional teams

Results and solution oriented

Strong project management skills

Excellent problem solving skills

Good prioritization and organizational skills

Works effectively on cross-functional teams

BS degree in life science, nursing or equivalent

≈5 to 8 years directly related work experience or equivalent

DESIRABLE QUALIFICATIONS:

Direct experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support in vascular devices.

Direct experience in peripheral vascular medical devices, diagnostic and/or interventional clinical trials.

Direct experience in an interventional catheterization lab or endovascular surgery environment.

Ability to train or guide other clinical affairs staff on a project by project basis.

OTHER PARTICULARS:

Travel up to 40% of the time, may include international, as well.

LOCATION: San Diego, California or remotely located.

PHYSICAL DEMANDS:

Office Environment

Must be able to travel with luggage and study materials

Ability to stand long periods of time in a cath lab environment

In this role, you have the opportunity to

The Clinical Research Associates (CRA) will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of cardiovascular and peripheral vascular diagnostic and therapeutic medical devices. CRAs support study activities to meet protocol and corporate objectives, maintaining regulatory compliance and professional integrity for our internal and external stakeholders.

You are responsible for

Become the study expert and be accountable for driving execution and oversight of all study related activities, including: Managing the study strategy (Investigational Plan), budget, resources, and timelines for assigned clinical trial(s)

Leads the clinical study team in coordinating study activities site screening, initiation, and monitoring visits including preparation and distribution of materials for in-house documentation and site readiness. Ability to train and support site staff and project staff on all aspects of the clinical monitoring and study protocol (investigators, coordinators, Philips staff, vendor staff/contract monitors).

Leads development of site and study documentation such as training materials, reports, consent documents, study operation manuals, monitoring plans and regulatory submissions for the screening, initiation, conduct and reporting of clinical trials.

Leads preparation and maintenance of manuals, forms, tracking tools and reports for AE reporting and medical monitor review.

Leads the clinical study team in clinical data management in CRF development, validation rules and other reporting and analysis tasks, reimbursement for sites.

Supports charter development, reporting and meeting requirements for CEC and DSMB conduct, as well as liaison with committees and members for scheduling and documentation.

Represent Clinical Affairs to key customers

Generates high quality clinical data and status reports to support management, project team, study reports, regulatory submissions and publications.

Coordinates and supports development of clinical study protocols and case report forms with expert input (such as MD, statistical).

Administrates and supports Core Lab activities between sites, Philips and core lab.

Ensuring quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed)

Support development of department SOPs and work instructions, support departmental planning.

Supports investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.

Communicates with team and department members.

Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.

May support project teams for product development.

Support department activities as required

Support corporate strategies in Clinical Affairs

To succeed in this role, you should have the following skills and experience

MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:

BS degree in life science, nursing or equivalent

5 years directly related work experience or equivalent

General knowledge of cardiovascular and/or peripheral vascular disease and therapies

Ability to independently oversee a study team and trial with little supervision

Understands databases, data analysis, and data presentation

Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

Ability to identify customer requirements and manage expectations for clinical studies

Good understanding of biostatistics and trial design

Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

Working knowledge of and ability to follow Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011, and Japanese regulations.

Follows established SOPs and work instructions.

Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support.

Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.

Working auditing and self-auditing skills

Working project management and vendor management skills

General clinical data monitoring skills: paper and EMR

Excellent/advanced oral and written communications skills

Proficient computer skills including word processing, spreadsheet generation and database querying and reporting skills.

Ability to be point of contact for investigators and site staff on a clinical trial.

Demonstrable skills in organizational and project administration skills, tracking study activities for timeliness and completeness.

High attention to detail and accuracy.

Takes ownership and self-motivated

Works effectively on cross-functional teams

Results and solution oriented

Strong project management skills

Excellent problem solving skills

Good prioritization and organizational skills

Works effectively on cross-functional teams

DESIRABLE QUALIFICATIONS:

Direct experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support in vascular devices.

Direct experience in peripheral vascular medical devices, diagnostic and/or interventional clinical trials.

Direct experience in an interventional catheterization lab or endovascular surgery environment.

Ability to train or guide other clinical affairs staff on a project by project basis.

OTHER PARTICULARS:

Travel up to 40% of the time, may include international, as well.

San Diego, California or remotely based

PHYSICAL DEMANDS:

Office Environment

Must be able to travel with luggage and study materials

Ability to stand long periods of time in a cath lab environment

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/Philips

Chronic

Disease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

#LI-PH1

Apply Now

Philips

Philips Jobs

Apply Now

Share

10 days 4 hours ago

Philips Electronics North America

apply

Clinical Research Associate Philips Electronics North America - San Diego, CA, United States

   

Location: San Diego, CA

Company Profile:
Since the introduction of the first Philips light bulb more than 120 years ago, innovation and a people-centric approach have always been at the core of our company.