Senior Clinical Research Associate -NYC/NJ/CT (REMOTE)

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 Senior Clinical Research Associate | NYC/NJ/CT 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 role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the Senior CRA 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 and will actively develop and expand the territory for clinical research, finding and developing new sites. 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

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial

• Conducts 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

• Drives remote/on-site monitoring and 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

• 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

• Completes 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

• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate

• Quality control visits if delegated by other roles and trained appropriately

CORE Competency Expectations

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively

• Understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law and guidelines

• Participatory 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

• Understand and analyze data/metrics and act appropriately

• Capable of managing complex issues, works in a solution-oriented manner

• Conducts root cause analysis and implements preventative and corrective action

• Experience with conducting site motivational visit designed to boost site enrollment

• Capable of mentoring junior CRAs on process/study requirements and is able to conduct co-monitoring visits where appropriate

Behavioral Competency Expectations

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills

• Demonstrated high level of monitoring skill with independent professional judgement

• Work highly independently across multiple protocols, sites and therapy areas

• High sense of accountability/urgency | Set priorities and handle multiple tasks simultaneously in a changing environment

• Works effectively in a matrix multicultural environment

• 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

Travel and Location Options

• Domestically and internationally approximately 65%-75%

• Expected travelling ~2-3 days/week

• New York City or New Jersey or Connecticut | Works Remote

Education

• Bachelor of Arts or Science with strong emphasis in science and/or biology

​Required

• Four years direct site management (monitoring) in a bio/pharma/CRO

MRLGCTO

#EligibleforERP

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.

Residents of Colorado

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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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.

Residents of Colorado:

Click here 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:

Relocation:

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Flexible Work Arrangements:

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Requisition ID:R203884