Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Main responsibilities:
* With the support of the 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 International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents;
* Gains an in-depth understanding of the study protocol and related procedures;
* 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 and 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;
* 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, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed;
* Works in partnership with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and Institutional Review Board/Institutional Ethics Committee and Regulatory Authorities in support of assigned sites;
* Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines;
* Supports audit/inspection activities as needed;
* Performs co-monitoring where appropriate
Main requirements:
* Bachelor's degree with strong emphasis in science (pharmacy/biology);
* Fluent in Portuguese and advanced English (verbal and written);
* Clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator ou similar;
* Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & 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;
* Ability to perform root cause analysis and implement preventative and corrective action;
* Works effectively in a matrix multicultural environment;
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 proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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
Job Description
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Main responsibilities:
* With the support of the 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 International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents;
* Gains an in-depth understanding of the study protocol and related procedures;
* 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 and 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;
* 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, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed;
* Works in partnership with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and Institutional Review Board/Institutional Ethics Committee and Regulatory Authorities in support of assigned sites;
* Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines;
* Supports audit/inspection activities as needed;
* Performs co-monitoring where appropriate
Main requirements:
* Bachelor's degree with strong emphasis in science (pharmacy/biology);
* Fluent in Portuguese and advanced English (verbal and written);
* Clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator ou similar;
* Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonisation Good Clinical Practice & country clinical research law & 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;
* Ability to perform root cause analysis and implement preventative and corrective action;
* Works effectively in a matrix multicultural environment;
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 proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
About the company
Merck & Co., Inc.,
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