Clinical Research Associate
hace 2 semanas
Overview
As a Clinical Research Associate (Level I) at Thermo Fisher Scientific, you will play a critical role in ensuring the success of our clinical trials. This position requires a detail-oriented individual with a strong understanding of clinical research and regulatory compliance.
Key Responsibilities
- Monitor investigator sites to ensure compliance with regulatory requirements and study protocols
- Conduct on-site file reviews and document observations in reports and letters
- Escalate observed deficiencies and issues to clinical management and follow up on resolution
- Participate in investigator meetings and help identify potential investigators
- Ensure required essential documents are complete and in place
- Conduct trial close out and retrieval of trial materials
Requirements
To be successful in this role, you will need a Bachelor's degree in a life sciences related field or a Registered Nursing certification and relevant formal academic / vocational qualification. You should also have minimal clinical monitoring experience, preferably in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care.
Preferred Qualifications
A valid driver's license is required in some cases. An equivalency, consisting of a combination of appropriate education, training and/or directly related experience, may be considered sufficient for an individual to meet the requirements of the role.
Skills and Abilities
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
- Good oral and written communication skills
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Ability to remain flexible and adaptable in a wide range of scenarios
Working Environment
This role will require you to work independently and as part of a team. You will be responsible for maintaining regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
What We Offer
At Thermo Fisher Scientific, we offer a competitive salary and a comprehensive benefits package. We also provide opportunities for professional growth and development, as well as a collaborative and dynamic work environment.
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