Title: Clinical Research Associate 4 Location: REMOTE with occasional field visits Duration: 12 Months (Contract-to-hire)
West cost location and West Coast sites
Job Overview
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.
Essential Functions
Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with the contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to proper protocol conduct and adherence to applicable regulations; escalate quality issues as appropriate.
Manage study progress by tracking:
Regulatory submissions and approvals
Recruitment and enrollment
Case report form (CRF) completion and submission
Data query generation and resolution
May support the study start-up phase.
Ensure copies/originals of site documents, as required, are available for filing in the Trial Master File (TMF).
Verify that the Investigator's Site File (ISF) is maintained according to GCP/ICH and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans.
Submit regular visit reports, generate follow-up letters, and complete other required study documentation.
Act as a mentor for clinical staff, including conducting co-monitoring and training visits.
Collaborate and liaise with study team members to support project execution.
If applicable, support development of project subject recruitment plans on a per-site basis.
If applicable, support site financial management according to the executed clinical trial agreement and retrieve invoices according to local requirements.
Qualifications
Bachelor's Degree in a scientific discipline or healthcare preferred.
Requires at least 4 years of on-site monitoring experience.
Equivalent combination of education, training, and experience may be accepted in lieu of a degree.
In-depth knowledge of and skill in applying applicable clinical research regulatory requirements, including GCP and ICH guidelines.
Strong therapeutic and protocol knowledge as provided in company training.
Computer proficiency, including Microsoft Word, Excel, and PowerPoint, and use of a laptop computer, iPhone, and iPad where applicable.
Strong written and verbal communication skills, including good command of English.
Strong organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $68.00/hr - $73.60/hr.
