Clinical Research Associate - Pharmaceutical
Behavioral Health Market Context
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Job Description
on of clinical trials, adhering strictly to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Your work will directly contribute to the development of life-saving medications and therapies.
Key responsibilities include monitoring clinical trial sites to ensure data accuracy, patient safety, and adherence to the study protocol. You will conduct pre-study, initiation, routine monitoring, and close-out visits. Verifying source data against Case Report Forms (CRFs), ensuring proper documentation, and resolving data queries are critical aspects of this role. You will serve as the primary liaison between the investigative sites and the sponsor, facilitating effective communication and problem-solving. Ensuring that study supplies are adequately maintained and that investigational products are managed correctly at the sites is also essential. This role requires thorough understanding of regulatory requirements, ethical considerations, and the clinical trial process. The ideal candidate will possess excellent organizational skills, strong analytical abilities, and a meticulous attention to detail. You must be adept at managing multiple tasks and prioritizing effectively in a dynamic environment. Travel to clinical sites will be a necessary component of this hybrid role. We seek a proactive and responsible individual committed to advancing pharmaceutical research.
Qualifications include a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role is required. Comprehensive knowledge of GCP, FDA regulations, and clinical trial conduct is essential. Strong understanding of medical terminology and disease processes is necessary. Excellent interpersonal, communication, and negotiation skills are vital for effective site management. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required. The ability to work independently and as part of a team in a hybrid setting is crucial. This is a fantastic opportunity for a dedicated professional to contribute to impactful pharmaceutical development within the Provo, Utah, US area.
Key responsibilities include monitoring clinical trial sites to ensure data accuracy, patient safety, and adherence to the study protocol. You will conduct pre-study, initiation, routine monitoring, and close-out visits. Verifying source data against Case Report Forms (CRFs), ensuring proper documentation, and resolving data queries are critical aspects of this role. You will serve as the primary liaison between the investigative sites and the sponsor, facilitating effective communication and problem-solving. Ensuring that study supplies are adequately maintained and that investigational products are managed correctly at the sites is also essential. This role requires thorough understanding of regulatory requirements, ethical considerations, and the clinical trial process. The ideal candidate will possess excellent organizational skills, strong analytical abilities, and a meticulous attention to detail. You must be adept at managing multiple tasks and prioritizing effectively in a dynamic environment. Travel to clinical sites will be a necessary component of this hybrid role. We seek a proactive and responsible individual committed to advancing pharmaceutical research.
Qualifications include a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role is required. Comprehensive knowledge of GCP, FDA regulations, and clinical trial conduct is essential. Strong understanding of medical terminology and disease processes is necessary. Excellent interpersonal, communication, and negotiation skills are vital for effective site management. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required. The ability to work independently and as part of a team in a hybrid setting is crucial. This is a fantastic opportunity for a dedicated professional to contribute to impactful pharmaceutical development within the Provo, Utah, US area.
Qualifications
- •The ideal candidate will possess excellent organizational skills, strong analytical abilities, and a meticulous attention to detail
- •You must be adept at managing multiple tasks and prioritizing effectively in a dynamic environment
- •Qualifications include a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field
- •A minimum of 2-3 years of experience as a Clinical Research Associate or in a similar clinical research role is required
- •Comprehensive knowledge of GCP, FDA regulations, and clinical trial conduct is essential
- •Strong understanding of medical terminology and disease processes is necessary
- •Excellent interpersonal, communication, and negotiation skills are vital for effective site management
- •Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required
- •The ability to work independently and as part of a team in a hybrid setting is crucial
Benefits
Responsibilities
- •This hybrid role offers a blend of on-site engagement for essential site visits and core team meetings, alongside remote flexibility for documentation and administrative tasks
- •You will play a vital role in ensuring the successful execution of clinical trials, adhering strictly to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements
- •Your work will directly contribute to the development of life-saving medications and therapies
- •Key responsibilities include monitoring clinical trial sites to ensure data accuracy, patient safety, and adherence to the study protocol
- •You will conduct pre-study, initiation, routine monitoring, and close-out visits
- •Verifying source data against Case Report Forms (CRFs), ensuring proper documentation, and resolving data queries are critical aspects of this role
- •You will serve as the primary liaison between the investigative sites and the sponsor, facilitating effective communication and problem-solving
- •Ensuring that study supplies are adequately maintained and that investigational products are managed correctly at the sites is also essential
- •This role requires thorough understanding of regulatory requirements, ethical considerations, and the clinical trial process
- •Travel to clinical sites will be a necessary component of this hybrid role
- •We seek a proactive and responsible individual committed to advancing pharmaceutical research
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