CLINICAL RESEARCH ASSOCIATE

Job Description We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are looking for a Clinical Research Associate (CRA) to join our team.
The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager this person will ensure compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
CRA will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites Also, CRA will actively develop and expand the territory for clinical research and will participate in internal meetings and workstreams as SME for monitoring processes and systems.
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.
o Data generated at site 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 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.
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.
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required Supports audit/inspection activities as needed.
Performs co-monitoring where appropriate.
Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Requirements.
Bachelor’s degree in science Minimum 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Fluency in English (verbal and written) and excellent communication skills.
Ability to travel domestically.
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 Proven skills in Site Management including management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgement.
Good IT skills Ability to understand and analyze data/metrics and act appropriately.
Capable of managing complex issues, solution-oriented approach Ability to perform root cause analysis and implement preventative and corrective action.
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.
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Please, no phone calls or emails.
Employee Status.
Regular Relocation.
VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Not Applicable Shift.
Valid Driving License.
Hazardous Material(s).
Job Posting End Date.
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Job Posting End Date.
A job posting is effective until PM 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.
R