ASSOCIATE 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 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.
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.
./B.
.
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 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.
Regular Relocation.
No relocation VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Remote Shift.
Valid Driving License.
Hazardous Material(s).
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.
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