Associate Clinical Research Associate

Job Description

THE OPPORTUNITY

With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager

throughout all phases of a clinical research study, taking responsibility of allocated sites.

WHAT YOU WILL DO

Develops strong site relationships and ensures continuity of site relationships through all

phases of the trial.

Performs clinical study site management/monitoring activities in compliance with ICH-GCP,

Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated

documents.

Gains an in-depth understanding of the study protocol and related procedures.

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve

Site Ready.

Participates & provides inputs on site selection and validation activities.

Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated atsite are complete, accurate and unbiased

o Subjects’ right, safety and well-being are protected

Conducts site visits including but not limited to validation visits, initiation visits, monitoring

visits, close-out visits and records clear, comprehensive and accurate visit & non-visit

contact reports appropriately in a timely manner.

Collects, reviews, and monitors required regulatory documentation forstudy start-up, study

maintenance and study close-out.

Communicates with Investigators and site staff on issues related to protocol conduct,

recruitment, retention, protocol deviations, regulatory documentation, site

audits/inspections and overall site performance.

Identifies, assesses and resolves site performance, quality or compliance problems and

escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA

Manager, CRM, TA Head and CRD as needed.

Works in partnership with GCTO country operations, finance, regulatory affairs,

pharmacovigilance, legal and regional operations, HQ functional areas and externally with

vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

Manages and maintains information and documentation in CTMS, eTMF and various other

systems as appropriate and per timelines.

Supports audit/inspection activities as needed.

Performs co-monitoring where appropriate.

Competency Expectations:

Fluent in Local Languages and English (verbal and written) and excellent

communication skills, including the ability to understand technical information.

Developing ability to present technical information with support.

Good understanding and working knowledge of clinical research, phases of clinical

trials, current GCP/ICH & country clinical research law & guidelines.

Good understanding of Global, Country/Regional CRA Guidelines and ability to work

within these guidelines.

Hands on knowledge of Good Documentation Practices

Developing skills in Site Management including management ofsite performance

and patient recruitment

Developing level of monitoring skill and independent professional judgment.

Good IT skills (Use of MS office, use of some clinical IT applications on computer,

tablet and mobile devices) and ability to adapt to new IT applications on various

devices.

Works with high quality and compliance mindset.

Capable of managing complex issues, solution-oriented approach.

Ability to perform root cause analysis and implement preventative and corrective

action.

WHAT YOU MUST HAVE

Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together

with at least 3 years of relevant experience in the healthcare field.

Or

Bachelor’s degree (or above) in a scientific / healthcare discipline together with at least 6

months of relevant experience in the healthcare field.

or

Bachelor’s degree (or above) in a non-scientific/healthcare discipline together with at least

2 years of relevant experience in the healthcare field

Required Skills:

Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Early Clinical Development, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Pharmaceutical Guidelines, Pharmaceutical Regulatory Affairs, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Root Cause Analysis (RCA)

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/31/2026

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