Senior Clinical Research Associate

Parexel

3+ years

Preferred by Comapny

India

11 Nov. 25, 2024

Job Description

Job Type: 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

Job Title: Clinical Research Associate (CRA)

Company: Parexel

Role Overview

As a Clinical Research Associate (CRA) at Parexel, you will serve as a key contact for investigator sites, ensuring the successful initiation, execution, and completion of clinical trials. You will contribute to the timely delivery of high-quality data while safeguarding the safety and well-being of trial participants. This role requires a dynamic professional with a proactive attitude, excellent problem-solving skills, and the ability to collaborate in a global, matrixed environment.

Key Accountabilities

Start-Up Phase (Site Identification to Pre-Initiation):

Act as Parexel’s primary point of contact with assigned sites, ensuring quality and delivery during start-up.
Conduct site feasibility, qualification, and pre-qualification activities, including remote Qualification Visits (QVs).
Negotiate, prepare, and facilitate the execution of Confidentiality Agreements (CDAs) and Clinical Site Agreements (CSAs).
Customize, review, and approve Informed Consent Forms (ICFs) and regulatory documents in compliance with country and client requirements.
Manage IRB/IEC and MoH/RA submissions, resolving conflicts and ensuring timely approvals.
Develop strategies for site activation, patient recruitment, and document compliance.
Maintain and update Clinical Trial Management Systems (CTMS).

Maintenance Phase (From Initiation to Close-Out):

Act as Parexel’s direct contact with sites, ensuring adherence to study protocols and addressing site issues.
Facilitate site access to study systems, ensuring compliance with training requirements.
Monitor site recruitment plans and implement improvements as necessary.
Perform on-site and remote monitoring visits, addressing data quality and integrity issues.
Review site documentation, evaluate compliance, and resolve any non-conformance issues.
Conduct site-specific training and assessments to ensure smooth trial execution.
Collaborate on corrective and preventive action plans to mitigate risks.

Overall Responsibilities:

Ensure timely and accurate completion of project goals.
Maintain a working knowledge of ICH-GCP guidelines, international/local regulations, and Parexel SOPs.
Ensure that assigned sites are audit and inspection ready.
Delegate and oversee administrative tasks as appropriate, providing mentorship and feedback.
Collaborate with cross-functional teams to drive project success.
Proactively communicate progress and challenges to management.

Skills and Competencies

Strong problem-solving and analytical skills with the ability to make independent decisions.
Excellent interpersonal, verbal, and written communication skills.
Proficiency in Clinical Trial Management Systems (CTMS), EDMS, and MS Office.
Ability to manage multiple tasks and prioritize effectively.
Proven ability to work in a matrix and virtual team environment.
Client-focused approach with strong consulting and mentoring skills.
Flexibility to travel and meet project-specific requirements.

Knowledge and Experience

Substantial experience in site management or clinical research with a solid understanding of clinical trial methodology and terminology.
Familiarity with regulatory submission processes and quality standards.
Experience with cross-cultural collaborations in a global work environment.

Education

Degree in biological sciences, pharmacy, nursing, or a related health discipline.
Equivalent experience in clinical research or site management may be considered.

Join Parexel to make a meaningful difference in advancing healthcare. Collaborate with global teams, grow your expertise, and be a part of a results-driven organization committed to innovation, quality, and patient safety.

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