Senior Clinical Research Associate- Portland, OR (Remote)

Merck & Co., Inc. Portland , OR 97228

Posted 2 months ago

Job Description:

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

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. The Senior 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.

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 Conference on 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 remote and on-site monitoring & oversight activities using various tools to ensure:

  • Data generated at the 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 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 the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and various other systems as appropriate and per timelines.

  • Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.

  • Supports and/or leads audit/inspection activities as needed.

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

Education and Experience:

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

  • Minimum of 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Travel Expectations:

  • Ability to travel domestically and internationally approximately 65%-75% of working time.

  • Expected traveling 2-3 days/week.

  • The current driver's license preferred.

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.

  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current Good Clinical Practice/ International Council for Harmonisation (GCP/ICH) & country clinical research law & guidelines.

  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines

  • Demonstrated ability to mentor/lead

  • Hands-on knowledge of Good Documentation Practices

  • Proven Skills in Site Management including independent 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 the 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

Behavioral Competency Expectations:

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

  • 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

  • Works with high quality and compliance mindset

  • Demonstrates commitment to Customer focus

This is a Remote Position

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.

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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:

Remote Work

Shift:

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Remote Medical Records Representative Needed For Our Gastroenterology Clinic In SW Portland

The Oregon Clinic

Posted 5 days ago

VIEW JOBS 9/23/2020 12:00:00 AM 2020-12-22T00:00 Over the past 26 years, The Oregon Clinic has grown from a small group of six medical practices with forty physicians, to one of the largest specialty medicine practices in the country. Today, The Oregon Clinic is a patient-centered, data-driven, professional medical and surgical specialty practice that serves patients throughout the Portland, Oregon metropolitan area and beyond with more than 250 providers spanning over 30 specialties. For the 6th year in a row The Oregon Clinic is proud to be one of the top ranked Large Employers in Oregon. Join our Team! The Gastroenterology West Specialty Group of The Oregon Clinic is seeking a full-time remote Medical Records Representative to join our busy clinic. The schedule is Monday - Friday from 8:30 a.m. to 5:00 p.m. Must live in Oregon or SW Washington. Occasional travel to the office will be required, including for orientation and training. This position is responsible for routing and following up on outside Release of Information requests, completing records requests for upcoming appointments or procedures, processing referrals, and following up on orders placed by providers. Position may also include scanning and indexing faxed documents, data-entry and other miscellaneous duties as requested. We are looking for a team member who is detail oriented, strong at multitasking and dedicated to high quality patient care. Starting pay range, based on experience: $15.61 - $18.37 per hour. Medical, Vision, and Rx Insurance is 100% paid for by The Oregon Clinic for full-time employees. Requirements: * Two years of experience in a medical office setting preferred * RHIT or RHIA certificate preferred * Prior experience working with Electronic Medical Records strongly preferred, specifically Centricity EMR * Moderate to advanced computer skills required. Ability to successfully utilize OnBase, Adobe PDF, Microsoft Office Programs, ActiveFax, and Internet Explorer on a daily basis * Excellent phone skills and customer service skills required * Attention to detail and organization skills required, and a strong commitment to patient privacy guidelines Additional Benefits: * 5% 401K Match + clinic funded pension-type plan * 70% Monthly Trimet Pass Subsidy * Company Provided Long-Term Disability/Life Insurance/EAP * Access to Pre-tax Medical Spending Account/Dependent Care Account * Employee discounts at Adidas, Nike, Sprint, Columbia, Apple, AT&T, and more! * Employee Imaging Discounts * Emergency Assistance while Traveling This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change a The Oregon Clinic Portland OR

Senior Clinical Research Associate- Portland, OR (Remote)

Merck & Co., Inc.