Job Description
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.
Responsibilities
- 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
visits, close-out visits and records clear, comprehensive and accurate visit & non-visit
- Data generated at site are complete, accurate and unbiased
- Subjects right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring
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.
Qualifications, Skills & Experience
- Bachelor's degree (or above) in a scientific / healthcare discipline together with at least 6 months of relevant experience in the healthcare field.
- 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 Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Developing skills in Site Management including management of site 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.
- Effective time management, organizational and interpersonal skills, conflict
management.
- Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Positive mindset, growth mindset, capable of working independently and being self-driven.
- Demonstrates and projects professional demeanor and communication consistent
with organizational policies and practices.
Required Skills
Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Data Analysis, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Medical Research, Pharmaceutical Guidelines, Pharmacovigilance, Proper Documentation, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Documents, Root Cause Analysis (RCA), Site Management, Solution-Oriented, Task Management
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
12/19/2025
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID R374016
