C-Clinical at Miami
Cns Sr Clinical Research Associate
C-Clinical at Miami, Miami, Florida, us, 33222
Our clinical research firm is expanding and we have an opportunity for a Senior CRA with our CNS pharmaceutical company client. We are looking for CRAs with 3 years+ experience, who currently live in Florida and are open for a short SWAT contract from September 2024 - December 2024. We have openings at ~100%, and the same company is potentially looking to hire 1 FTE internally. If you want to work for a great sponsor - look no further. Our group working with this client is rapidly growing, they enhance the clients' culture as well-established professionals - and we are all passionate about doing life-changing clinical research. C-Clinical wants to be in business with like-minded people. If you meet the qualifications and this sounds like you, apply today! Please fill out the intro application survey sent via email after you apply. Thank you!Responsibilities:
Sr. CRA must be based in FLORIDA, USA (on-site monitoring visits required)Interfaces with the study team to ensure timely initiation and completion of clinical trialsResponsible for the identification, evaluation, and qualification of investigators and sitesMay prepare and submit essential document packages required for clinical site initiationPerforms on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondenceReviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targetsMay be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidanceEnsure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsIdentify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authoritiesEnsure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor the study database for missing or discrepant data compared to the source record at the clinical siteEnsure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervisionAttend investigators’ meetings, project team meetings, and teleconferences, as needed.Understands and applies knowledge regarding local, state, country regulations (i.e., TGA, etc.) and ICH-GCPMaintain training on ICH-GCP, study protocol, and client proceduresQualifications:
3 years or more as a CRA with site monitoring responsibility And 1 year or more CNS3 years or more as a CRA with site monitoring responsibility And 1 year or more in a complex indication with in-patient monitoring3 years or more as a CRA with site monitoring responsibility bilingual in Spanish AND English.The candidate possesses a 4-year university degree, ideally in a scientific fieldMust have working rights in the United StatesMust be located in FLORIDA, within 1 hour of an airportThe candidate must have availability for this contract for September-December 2024. No promise of renewal.Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminologyBi-lingual is a plusMust be proficient at tactfully managing intra-team communication, as well as interpersonal communicationCompensation:
$65 - $90 hourly
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Sr. CRA must be based in FLORIDA, USA (on-site monitoring visits required)Interfaces with the study team to ensure timely initiation and completion of clinical trialsResponsible for the identification, evaluation, and qualification of investigators and sitesMay prepare and submit essential document packages required for clinical site initiationPerforms on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondenceReviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targetsMay be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidanceEnsure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsIdentify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authoritiesEnsure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor the study database for missing or discrepant data compared to the source record at the clinical siteEnsure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervisionAttend investigators’ meetings, project team meetings, and teleconferences, as needed.Understands and applies knowledge regarding local, state, country regulations (i.e., TGA, etc.) and ICH-GCPMaintain training on ICH-GCP, study protocol, and client proceduresQualifications:
3 years or more as a CRA with site monitoring responsibility And 1 year or more CNS3 years or more as a CRA with site monitoring responsibility And 1 year or more in a complex indication with in-patient monitoring3 years or more as a CRA with site monitoring responsibility bilingual in Spanish AND English.The candidate possesses a 4-year university degree, ideally in a scientific fieldMust have working rights in the United StatesMust be located in FLORIDA, within 1 hour of an airportThe candidate must have availability for this contract for September-December 2024. No promise of renewal.Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminologyBi-lingual is a plusMust be proficient at tactfully managing intra-team communication, as well as interpersonal communicationCompensation:
$65 - $90 hourly
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