Merck & Co Hiring for Clinical Research Associate – South Region (REMOTE) job in Rahway Full Time

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.

We are seeking a Growth and Improvement minded Clinical Research Associate – South Region that can help drive our Strategic Operating Priorities.

• Invent – Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute – Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt – Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent – We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards – Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Clinical Research Associate (CRA) – South Region is accountable for achievement and compliance for assigned protocols and sites in a-country.- Under the oversight of the CRA Manager the person ensures compliance of study conduct with-ICH/GCP and country regulations, company policies and procedures, quality standards and-adverse event reporting requirements internally and externally. You will be the primary site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.

The successful candidate actively develops and expands the territory for clinical research, finding and developing new-sites and participates in internal meetings and workstreams as SME for monitoring processes and-systems.

Key Functions

• Work Independently and as a Team member with Integrity – Precision – Accomplishment – Motivational Ambition – Respect – Inclusion
• Capable of managing complex issues, works in a solution-oriented manner
• Develops strong site relationships and ensures continuity of site relationships through all-phases of the trial
• Completes root cause analysis and implements preventative and corrective action
• Drives strategic 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 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 remote and on-site monitoring as well as oversight activities using various tools to ensured 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 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 CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD
• 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
• Supports and/or leads audit/inspection activities
• Conducts co-monitoring visits
• 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

Travel

• Domestic and International approximately 65%-75% – Two to three days per week-

Education

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

Experience – Skills – Knowledge

• Two years direct site management (monitoring) experience in a bio/pharma/CRO
• Principled verbal and written communications – Fluent in Local Languages and English (verbal and written) including the ability to understand and present technical information effectively
• Good understanding and working knowledge of clinical research, phases of clinical trials,-current GCP/ICH and country clinical research law and guidelines
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability-to work within these guidelines
• Direct 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 judgment
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet-and mobile devices) and ability to adapt to new IT applications on various devices
• Ability to understand and analyze data/metrics and act appropriately
• Effective time management, organizational and interpersonal skills, conflict management,-problem solving skills
• Demonstrated high level of monitoring skill with independent professional judgement
• Able to work highly independently across multiple protocols, sites and therapy areas
• High sense of accountability/urgency – Ability to set priorities and handle multiple tasks-simultaneously in a changing environment
• Works effectively in a matrix multicultural environment- Ability to establish and maintain-culturally sensitive working relationships
• Demonstrates commitment to Customer focus
• Works with high quality and compliance mind-set
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Demonstrates and projects professional demeanor and communication consistent with-organizational policies and practices

MRLGCTO

#EligibleforERP

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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.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

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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.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:
$88,480.00 – $139,100.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. – For Washington State Jobs, a summary of benefits is listed here .

Learn more about your rights, including under California, Colorado and other US State Acts

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:
Not Specified

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
None

Requisition ID:R237597