Work in Washington Veterans Jobs

Job Information

Merck Associate Clinical Research Associate - WA/CA/ID/NV/OR (Remote) in Olympia, Washington

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Clinical Research and Pharmacovigilance teams 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.

Primary Responsibilities:

  • With support, 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 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 & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

  • Participates & provides inputs on site selection and validation activities.

  • Performs oversight activities including on-site monitoring and remote monitoring 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.

  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

  • Primary point of contact for 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) and CRA Manager.

  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

Education Minimum Requirements:

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

  • Recommended two years of clinical research experience. Related clinical research experience may include Nursing, Study Coordinator, Clinical Trial Coordinator (CTC) or similar.

Required Experience and Skills:

  • 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 Clinical Research 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.

Preferred Experience and Skills:

  • Effective time management, organizational and interpersonal skills, conflict management.

  • Able to work with other experienced research professions to develop skills 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.

This is a 100% remote oppurtunity

#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., Kenilworth, 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

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

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.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Work Week

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R160439

DirectEmployers