Senior Clinical Research Associate

Parexel

2+ years

Not Disclosed

Remote

10 Oct. 30, 2024

Job Description

Job Type: Full Time 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

About This Role

Key Accountabilities:

Start-up (From Site Identification Through Pre-Initiation):

Serve as Parexel’s primary contact for assigned sites, ensuring quality and timely delivery during the start-up phase.
Build and maintain relationships with investigators and site staff.
Conduct feasibility assessments and manage site pre-qualification and qualification activities, including:
- Preparation and negotiation of Confidentiality Agreements (CDA), Clinical Site Agreements (CSA), and amendments.
- Conducting remote Qualification Visits (QVs).
Generate visit/contact reports, identifying and resolving site issues proactively.
Develop strategies for country-specific and site-specific document management, including Informed Consent Forms (ICF) and regulatory submissions.
Prepare and submit applications to IRB/IEC and MoH/RA, ensuring all follow-ups are handled until final approvals are received.
Maintain accurate records in the trial master file and update Clinical Trial Management Systems (CTMS) promptly.

Maintenance (From Initiation Through Close-Out):

Act as the primary contact for assigned sites, ensuring adherence to study protocols and resolving site issues.
Facilitate site access to relevant study systems and ensure compliance with training requirements.
Evaluate on-site staff assignments and implement corrective actions as needed.
Monitor and follow up on site issues, data quality, and compliance with training requirements.
Conduct on-site and remote visits, generating reports and evaluating site performance.

Overall Accountabilities:

Ensure timely completion of project goals and maintain accurate updates in trial management systems.
Collaborate with team members to meet project objectives and provide strategies for efficient project planning.
Ensure all assigned sites are audit-ready and compliant with ICH-GCP and local regulations.
Delegate tasks to the Administrative Support Team, providing guidance and feedback on performance.
Foster a positive, results-oriented work environment and maintain high-quality work standards.

Skills

Strong problem-solving abilities and initiative to work independently.
Excellent presentation and client-focused communication skills.
Ability to prioritize multiple tasks and make decisions in ambiguous situations.
Proficient in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office products.
Strong interpersonal skills with a commitment to high-quality work and team collaboration.
Willingness to travel as required and mentor team members.

Knowledge and Experience

Substantial site management experience or equivalent experience in clinical research, with a strong understanding of clinical trial methodologies and terminology.

Education

Educated to degree level in biological sciences, pharmacy, or a health-related discipline, or equivalent nursing qualification or relevant experience.

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