Senior Clinical Research Associate (California)
Boost your chances before you apply.
Ergomed
San Francisco, CA, US
Summary
Perform pre-study, initiation, interim, and close-out monitoring visits to ensure site adequacy and compliance. Mentor junior staff and verify that investigators have the necessary qualifications and resources to conduct clinical studies.
Job Description
Company Description
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
- Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
- Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period.
- Trains investigational site staff as necessary
- When applicable, supports preparation of regulatory and / or EC submissions
- Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease
- Full working proficiency in English
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel nationally
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
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Training and career development opportunities internally
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Strong emphasis on personal and professional growth
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Friendly, supportive working environment
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Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Company size
1,001-5,000 employees
Industry
Biotechnology Research
Org type
Privately Held
Headquarters
Guildford, Surrey
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Company size
1,001-5,000 employees
Industry
Biotechnology Research
Org type
Privately Held
Headquarters
Guildford, Surrey