Remote Women's Fertility Clinical Research Associate Iii

2+ years

$49 to $50 per hour

Remote

10 Sept. 18, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Remote Clinical Research Associate III

Requirements:

Work Schedule: Monday to Friday, either 7:00 AM - 3:30 PM or 8:00 AM - 4:30 PM EST.

Qualifications:

Bachelor’s degree (BS/BA).
Minimum of 2 years of site management and field monitoring experience.
Knowledge of applicable standards and regulations for clinical trials.
Excellent oral and written communication skills.
Strong planning skills with the ability to create and track detailed project plans.
Proven interpersonal, leadership, organizational, and effective time management skills.
Proficiency in Microsoft Word, Excel, and basic templates.
Ability to work independently and within a cross-functional team, effectively identifying and escalating site/monitoring-related issues to management in a timely manner.

Preferred:

Experience in women's fertility studies.
Experience with VD studies.
Familiarity with the Medidata RAVE system.

Duties:

Conduct site initiation, interim, and close-out monitoring visits.
Verify that required clinical data entered in the electronic case report form (eCRF) is accurate and complete.
Manage site communication and escalate issues to leadership as needed.
Apply query resolution techniques both remotely and on-site, providing guidance to site staff and driving queries to resolution within agreed timelines.
Regularly review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile its contents with the Trial Master File (TMF).
Ensure that the investigator/physician site is aware of the requirements for archiving essential documents according to local guidelines and regulations.
Document activities through confirmation letters, follow-up letters, and trip reports.
Provide site support throughout the study lifecycle, from site identification through close-out.
Attend and participate in internal meetings.

We look forward to your application!

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Remote Women's Fertility Clinical Research Associate Iii

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