Clinical Research Associate - Remote

2+ years

$91,600.00 - $144,100.00

Remote, USA

15 June 10, 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, 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

Position: Clinical Research Associate

Company: Merck & Co.

Location: Rahway, New Jersey, United States

Job Type: Full-time

Category: Clinical Research

Post Date: 06/05/2024

Description:

As a Clinical Research Associate (CRA) at Merck & Co., you will be accountable for performance and compliance for assigned protocols and sites in the country. Reporting to the CRA manager, you will ensure study conduct compliance with ICH/GCP and country regulations, policies, and procedures. The role involves acting as the primary site contact and manager throughout all phases of a clinical research study, with a focus on expanding the territory for clinical research and developing new sites. Additionally, you will participate in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

Responsibilities:

Develop strong site relationships and ensure continuity through all trial phases.
Perform clinical study site management/monitoring activities in compliance with relevant guidelines, laws, and protocols.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate tasks with other sponsor roles to achieve Site Ready status.
Conduct remote and on-site monitoring activities to ensure data accuracy and subject safety.
Conduct site visits, including validation, initiation, monitoring, and close-out visits.
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
Communicate with Investigators and site staff on protocol-related issues and overall site performance.
Identify, assess, and resolve site performance or compliance problems and escalate as appropriate.
Collaborate with internal and external stakeholders to support assigned sites.
Manage and maintain information in various systems such as CTMS and eTMF.
Contribute to CRA team knowledge by acting as an SME and sharing best practices.
Support audit/inspection activities as needed.
Contribute to the identification of new potential sites and develop strong clinical research capabilities.

Travel Requirements:

Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected traveling approximately 2-3 days/week.
Current driver's license preferred.

Qualifications, Skills & Experience:

Core Competency Expectations:

Fluent in Local Languages and English (verbal and written) with excellent communication skills.
Good understanding of clinical research, GCP/ICH guidelines, and local clinical research laws.
Hands-on knowledge of Good Documentation Practices.
Proven skills in site management, including patient recruitment.
Proficient in MS Office and various clinical IT applications.
Ability to manage complex issues and work in a solution-oriented manner.
Effective time management, organizational, and interpersonal skills.
Ability to work independently and collaborate in a multicultural environment.
High sense of accountability and urgency.
Demonstrates commitment to customer focus, quality, and compliance.

Experience Requirements:

Minimum 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

Preferred: B.A./B.S. with a strong emphasis in science and/or biology.

Salary Range:

$91,600.00 - $144,100.00

Benefits:

Bonus eligibility, long-term incentive if applicable, health care and other insurance benefits, retirement benefits, paid holidays, vacation, and sick days.

Application Deadline: 06/12/2024

Note: This job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please ensure you apply before the end date.

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Clinical Research Associate - Remote

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