Clinical Research Associate (Alabama/Louisiana/Mississippi) -REMOTE
Merck
Remote
clinical research
research
remote
research
clinical research
monitoring
manager
compliance
protocol
collaboration
science
people
separation
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September 23, 2022
Merck
Birmingham, Alabama
FULL_TIME
Our Clinical Research and Pharmacovigilance team pushes 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.
We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process Position Description:* The Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement Primary Responsibilities* + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 Council for Harmonisation Good Clinical Practice (ICH-GCP), Sponsor Standard Operating Procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents. + Gains an in-depth understanding of the study protocol and related procedures.
+ Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready. + Participates and provides inputs on site selection and validation activities. + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit and 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 Clinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM), Partner Line Manager (PLM) and Regional Clinical Project Manager (RCPM).
+ Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Trial Master File (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 and/or leads audit/inspection activities as needed.
+ Performs remote and on-site monitoring and oversight activities using various tools to ensure; 1) Data generated at site are complete, accurate and unbiased and 2) Subjects' right, safety and well-being are protected.Position Qualifications:*.Education Minimum Requirements* + Bachelor of Arts or Science Degree preferred with a strong emphasis in science and/or biology + Min.
2 years of direct site monitoring experience in a bio/pharma/Clinical Research Organization (CRO) (or as country specifically requires).Travel* + Ability to travel domestically and internationally approximately 65%-75% of working time + Expected traveling ~2-3 days/week + This position is remote.MRLGCTO*.\*.ETJOBS*. This is a remote-based role* We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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 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 NOTICE FOR INTERNAL APPLICANTS* In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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 Residents of Colorado* Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role's pay range New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
* Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld).
US and Puerto Rico Residents Only:* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf) EEOC GINA Supplement? OFCCP EEO Supplement (https://www.dol.
gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf) Pay Transparency Nondiscrimination 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 Residents of Colorado:* Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role's pay range 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:* Remote Work.
Shift:*.Valid Driving License:* Yes.Hazardous Material(s):*.Number of Openings:* 1.Requisition ID:* R195595.
We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process Position Description:* The Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement Primary Responsibilities* + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 Council for Harmonisation Good Clinical Practice (ICH-GCP), Sponsor Standard Operating Procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents. + Gains an in-depth understanding of the study protocol and related procedures.
+ Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready. + Participates and provides inputs on site selection and validation activities. + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit and 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 Clinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM), Partner Line Manager (PLM) and Regional Clinical Project Manager (RCPM).
+ Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Trial Master File (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 and/or leads audit/inspection activities as needed.
+ Performs remote and on-site monitoring and oversight activities using various tools to ensure; 1) Data generated at site are complete, accurate and unbiased and 2) Subjects' right, safety and well-being are protected.Position Qualifications:*.Education Minimum Requirements* + Bachelor of Arts or Science Degree preferred with a strong emphasis in science and/or biology + Min.
2 years of direct site monitoring experience in a bio/pharma/Clinical Research Organization (CRO) (or as country specifically requires).Travel* + Ability to travel domestically and internationally approximately 65%-75% of working time + Expected traveling ~2-3 days/week + This position is remote.MRLGCTO*.\*.ETJOBS*. This is a remote-based role* We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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 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 NOTICE FOR INTERNAL APPLICANTS* In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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 Residents of Colorado* Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role's pay range New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
* Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld).
US and Puerto Rico Residents Only:* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf) EEOC GINA Supplement? OFCCP EEO Supplement (https://www.dol.
gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf) Pay Transparency Nondiscrimination 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 Residents of Colorado:* Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role's pay range 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:* Remote Work.
Shift:*.Valid Driving License:* Yes.Hazardous Material(s):*.Number of Openings:* 1.Requisition ID:* R195595.
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