Clinical Research Associate (Pharmaceutical)
Behavioral Health Market Context
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Job Description
es, and regulatory requirements. You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data accuracy, patient safety, and overall trial integrity. The ideal candidate will possess a strong understanding of clinical trial processes, excellent communication skills, and the ability to build rapport with investigators and site staff. A commitment to scientific rigor and ethical conduct is paramount.
Responsibilities:
Perform site selection, initiation, interim monitoring, and close-out visits for clinical trials. Verify the accuracy, completeness, and timeliness of clinical data by reviewing source documents against the Case Report Forms (CRFs). Ensure adherence to the study protocol, Standard Operating Procedures (SOPs), GCP, and all applicable regulatory requirements. Monitor patient safety and report adverse events according to protocol and regulatory guidelines. Train and support site staff on study-related procedures and requirements. Build and maintain strong working relationships with investigators, study coordinators, and other site personnel. Identify potential risks and issues at clinical trial sites and implement appropriate corrective and preventive actions (CAPA). Manage study supplies and equipment at investigational sites. Prepare site monitoring reports and communicate findings and recommendations to project teams. Ensure all essential regulatory documents are maintained at the study sites.
Qualifications:
Bachelor's degree in a life science, nursing, or related field. Minimum of 3 years of experience as a Clinical Research Associate, with a proven track record of successful site monitoring. In-depth knowledge of GCP, ICH guidelines, and FDA regulations. Experience with various therapeutic areas is a plus. Excellent understanding of clinical trial processes and documentation. Strong analytical and problem-solving skills. Exceptional organizational and time management abilities. Proficient in using electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent written and verbal communication skills, with strong interpersonal abilities. Willingness and ability to travel extensively (up to 60%). This is a fantastic opportunity for a motivated CRA to contribute to groundbreaking pharmaceutical research.
Responsibilities:
Perform site selection, initiation, interim monitoring, and close-out visits for clinical trials. Verify the accuracy, completeness, and timeliness of clinical data by reviewing source documents against the Case Report Forms (CRFs). Ensure adherence to the study protocol, Standard Operating Procedures (SOPs), GCP, and all applicable regulatory requirements. Monitor patient safety and report adverse events according to protocol and regulatory guidelines. Train and support site staff on study-related procedures and requirements. Build and maintain strong working relationships with investigators, study coordinators, and other site personnel. Identify potential risks and issues at clinical trial sites and implement appropriate corrective and preventive actions (CAPA). Manage study supplies and equipment at investigational sites. Prepare site monitoring reports and communicate findings and recommendations to project teams. Ensure all essential regulatory documents are maintained at the study sites.
Qualifications:
Bachelor's degree in a life science, nursing, or related field. Minimum of 3 years of experience as a Clinical Research Associate, with a proven track record of successful site monitoring. In-depth knowledge of GCP, ICH guidelines, and FDA regulations. Experience with various therapeutic areas is a plus. Excellent understanding of clinical trial processes and documentation. Strong analytical and problem-solving skills. Exceptional organizational and time management abilities. Proficient in using electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent written and verbal communication skills, with strong interpersonal abilities. Willingness and ability to travel extensively (up to 60%). This is a fantastic opportunity for a motivated CRA to contribute to groundbreaking pharmaceutical research.
Qualifications
- •A commitment to scientific rigor and ethical conduct is paramount
- •Bachelor's degree in a life science, nursing, or related field
- •Minimum of 3 years of experience as a Clinical Research Associate, with a proven track record of successful site monitoring
- •In-depth knowledge of GCP, ICH guidelines, and FDA regulations
- •Excellent understanding of clinical trial processes and documentation
- •Strong analytical and problem-solving skills
- •Exceptional organizational and time management abilities
- •Proficient in using electronic data capture (EDC) systems and clinical trial management systems (CTMS)
- •Excellent written and verbal communication skills, with strong interpersonal abilities
- •Willingness and ability to travel extensively (up to 60%)
- •This is a fantastic opportunity for a motivated CRA to contribute to groundbreaking pharmaceutical research
Benefits
Responsibilities
- •As a CRA, you will be instrumental in ensuring the successful execution of clinical trials according to protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements
- •You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data accuracy, patient safety, and overall trial integrity
- •The ideal candidate will possess a strong understanding of clinical trial processes, excellent communication skills, and the ability to build rapport with investigators and site staff
- •Perform site selection, initiation, interim monitoring, and close-out visits for clinical trials
- •Verify the accuracy, completeness, and timeliness of clinical data by reviewing source documents against the Case Report Forms (CRFs)
- •Ensure adherence to the study protocol, Standard Operating Procedures (SOPs), GCP, and all applicable regulatory requirements
- •Monitor patient safety and report adverse events according to protocol and regulatory guidelines
- •Train and support site staff on study-related procedures and requirements
- •Build and maintain strong working relationships with investigators, study coordinators, and other site personnel
- •Identify potential risks and issues at clinical trial sites and implement appropriate corrective and preventive actions (CAPA)
- •Manage study supplies and equipment at investigational sites
- •Prepare site monitoring reports and communicate findings and recommendations to project teams
- •Ensure all essential regulatory documents are maintained at the study sites
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