Clinical Research Associate

Clinical Research Associate (CRA) With support of SrCRA/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:

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.




• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.




• Gain 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.




• Participate & provide inputs on site selection and validation activities.




• Perform remote and on-site monitoring & oversight activities using various tools.




• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact report appropriately in a timely manner.




• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.




• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.



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  • Identify, assess and resolve site performance, quality or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
  
  



• Work 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




• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.




• Support audit/inspection activities as needed.




• Perform co-monitoring where appropriate.

QUALIFICATIONS, SKILLS & EXPERIENCE

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 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.




• Work 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.

Behavioral Competency Expectations:

• 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.




• B.A./B.S. required with strong emphasis in science and/or biology.




• Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.




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

Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R267929