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Medical Affairs Associate Clinical Research CRA

Location
Mountain View, CA

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Profile

Who We Are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
The Medical Affairs Department within **MEMBERS ONLY**SIGN UP NOW***.. has an immediate need for a full-time Medical Affairs Associate - Clinical Research (
CRA)
based in our Downtown Mountain View offices.
As the size and popularity of our Personal Genome Service© continues to grow and create tremendous opportunities to transform healthcare, the Medical Affairs department is under increasing demand. Medical affairs activities touch many facets of the company’s efforts including:
Advising on strategy for health-related initiatives.
Maintaining credibility through medical review of health-related products, activities and associated health information communications and claims.
Strengthening relationships and engaging in two-way communications with key healthcare stakeholders.
Advising on and participating in consumer & professional education.
Supporting product adoption in the clinical environment.
Advising on and participating in health-product quality assurance and post-market surveillance.
Serving internally as the voice of the medical and patient communities.
Working closely with, and under the guidance of, the Director of Medical Affairs, the Medical Affairs
CRA
will be a valuable contributor, helping the Medical Affairs team successfully meet the needs of the company in several of these key areas.
What you’ll do
As a Medical Affairs
CRA
you will facilitate the betterment of all proposed product and non-product based clinical research activities by:
Developing strong relationships with co-workers on Research, Legal, Quality Assurance, Regulatory Affairs, Business Development, and Product teams.
Acting as an internal medical and clinical research domain expert, and through that lens, contribute to the planning, development and execution of clinical research initiatives.
Evaluating objectives and methodology for appropriateness and feasibility.
Identifying risks and proposing mitigation strategies.
When needed, identifying and compliantly engaging outside clinical domain experts.
Ensuring study compliance and quality by reviewing adverse events and complaints and recommending corrective actions when needed.
Reviewing (and at times approve) study documents including, but not limited to: proposals, protocols, consent documents, inclusion/exclusion criteria, IRB submissions, adverse event monitoring plans and logs,
SOPs and work instructions
Supporting the development of (inter-)departmental SOPs.
As a Medical Affairs Team Member:
Represent the ‘consensus medical opinion’ at every opportunity.
Develop strong relationships with fellow Medical Affairs co-workers and have a working. understanding of the various roles and functions of each team-member - including cross-covering responsibilities if needed.
Maintain proficiency in the understanding of all 23andMe health-related products.
Participate in weekly team meetings and provide progress reports to medical affairs leadership.
Occasionally collaborate with co-workers from Product Science, Marketing, and Education teams.
Occasionally support efforts at remote locations such as clinical or education conferences, partner meetings, and KOL development.
Maintain a working understanding of the compliance, regulatory, and quality policies and procedures that pertain to all health-related products and related communications.
Maintain professional integrity in all internal and external stakeholder interactions
What you’ll bring
Professional Requirements:
Minimum BS in a clinically-oriented field such as BSN, MSN, APRN, NP, DN, DNSc, PA
CCRA credential
Board certification in your practice area (as available)
State-issued medical license in your practice area (California preferred)
Minimum of two years of clinical experience beyond training
Proven proficiency in understanding the complex interplay of industry-based research objectives and ethical treatment of human subjects
Direct experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management (preferred)
Technical Requirements:
High attention to detail and accuracy
Good understanding of biostatistics, trial design, databases, data analysis, and data presentation
Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Working knowledge of PC operation and cloud & non-cloud based software (Eg. Google Docs & Mail, DropBox, Word, Excel, PowerPoint)
Working knowledge of online clinical resources and databases (Eg. NIH resources, UpToDate, Medscape, others)
Other Requirements:
A level of professionalism consistent with 23andMe’s values, vision, and mission.
Strong interpersonal and communication skills with demonstrated ability to successfully support complex clinical trials.
Demonstrated decision-making, problem-solving, organizational, and analytical skills.
Ability to work independently and collaboratively in a fast-paced, complex, and at times demanding, high-tech startup work environment, with the ability to carry out complicated assignments and adapt to changing situations and priorities.
Demonstrated ability to work as a dependable and supportive member of a team in addition to excelling as an individual contributor.
About Us
**MEMBERS ONLY**SIGN UP NOW***.. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has over 5 million customers worldwide, with ~85 percent of customers consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at ****At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at ****. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you

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