Associate Clinical Research Associate

Job Description

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Secondary Language(s) Job Description:

We are looking for an Ass. Clinical Research Associate to join our Clinical Research Monitor Team.

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 include, but are not limited to:

• 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: 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 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 for study 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
• 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.

Experience Requirements:

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

Educational Requirements:

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

CORE 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.
• 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

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote