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Aptude
Altamonte Springs, FL | Contractor
$54k-71k (estimate)
2 Months Ago
Clinical Research Associate II
Aptude Altamonte Springs, FL
$54k-71k (estimate)
Contractor 2 Months Ago
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Aptude is Hiring a Remote Clinical Research Associate II

Summary: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Monitors during clinical research studies to ensure trials are being conducted in accordance with widely accepted clinical practices.
Conducts on-site and remote monitoring; develops tools, procedures and processes to ensure quality monitoring.
Responsibilities:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
guidelines.
Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to
manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to
applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case
report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the
Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by
submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve
invoices according to local requirement.

Skills: Above-average interpersonal and organizational skills. Proficient use of Microsoft Office. Fluent in local language, spoken and written. Fluent in written English language. Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment. Ability to maintain confidentiality. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Education/Experience: 1-2 years of CRA experience required.

Job Type: Contract

Pay: Up to $47.00 per hour

Schedule:

  • 8 hour shift

Work Location: Hybrid remote in Altamonte Springs, FL 32701

Job Summary

JOB TYPE

Contractor

SALARY

$54k-71k (estimate)

POST DATE

01/15/2023

EXPIRATION DATE

02/12/2023

WEBSITE

apptude.com

HEADQUARTERS

Aurora, IL

SIZE

<25

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