Senior Initiation Clinical Research Associate

3-7 years

Not Disclosed

Bangalore

10 May 22, 2024

Job Description

Job Type: Full Time Education: Any Graduate Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate

Company: Parexel

Location: Near Boston, Massachusetts, and Durham, North Carolina

Job Type: Full Time

Function: Clinical Research

Job Description:

At Parexel, we share a common goal - to improve the world's health. From clinical trials to regulatory consulting and market access, our clinical development solutions are driven by a deep conviction in our mission. As a Senior Clinical Research Associate, you will contribute to the development of therapies that benefit patients, working with empathy, commitment, and a personal touch.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Serve as Parexel’s direct point of contact with assigned sites, ensuring quality and delivery during the start-up phase.
Build relationships with investigators and site staff.
Conduct feasibility and/or site pre-qualification and qualification activities.
Negotiate and execute Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and amendments.
Prepare for and conduct Qualification Visits (QVs).
Generate visit/contact reports and address site issues.
Develop strategies for regulatory document preparation, IRB/IEC and MoH/RA submission/approval, and patient recruitment & retention.

Maintenance (from initiation through close out):

Assess overall study implementation and adherence to protocol at clinical sites.
Address and resolve site issues and provide ongoing support.
Conduct on-site visits and remote visits/contacts as needed.
Review and approve updated/amended site documentation.
Evaluate site recruitment plan and provide strategy for improvements.
Monitor and maintain compliance with regulations and guidelines.
Delegate administrative tasks and guide support team members.

Overall Accountabilities from Site Identification to Closeout:

Ensure timely completion of project goals and update of trial management systems.
Work with team members to meet project goals and encourage support.
Maintain compliance with regulations, SOPs, and training requirements.
Provide input for Performance Development Conversations.
Act as a mentor and role model for team members.

Skills:

Strong problem-solving skills
Initiative and ability to work independently
Excellent presentation and client-focused approach
Flexibility and ability to prioritize tasks
Strong computer and interpersonal skills
Attention to detail and sense of urgency
Ability to work in a team and across cultures

Knowledge and Experience:

Substantial Site Management experience or equivalent in clinical research
Understanding of clinical trials methodology and terminology

Education:

Degree in biological science, pharmacy, or related discipline preferred, or equivalent experience

Note: Must hold a driver’s license where required.

Parexel, headquartered near Boston, Massachusetts, and in Durham, North Carolina, employs over 16,000 people globally, supporting clients in over 100 countries. We offer comprehensive drug development capabilities, including global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services, to move you smoothly through the development journey.

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Senior Initiation Clinical Research Associate

Job Description

Job Title: Senior Clinical Research Associate

Job Description:

Key Accountabilities:

Skills:

Knowledge and Experience:

Education:

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