Associate Clinical Research Associate (Remote -West Region)

With support of SrCRA/CRA and/or CRA Manager, 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.
• 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.
• Supports audit/inspection activities as needed.
• 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
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and Subjects’ right, safety and well-being are protected
• Gains an in-depth understanding of the study protocol and related procedures.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• 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.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Participates & provides inputs on site selection and validation activities.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Performs co-monitoring where appropriate.
• 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 as needed.

Competency Expectations:

• Developing skills in Site Management including management of site performance and patient recruitment
• Developing level of monitoring skill and independent professional judgment.
• 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.
• Capable of managing complex issues, solution-oriented approach.
• Ability to perform root cause analysis and implement preventative and corrective action.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Hands on knowledge of Good Documentation Practices
• Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.
• Works with high quality and compliance mindset.
• 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.

Behavioral Competency Expectations:

• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
• Effective time management, organizational and interpersonal skills, conflict management
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.

Education Requirement:

• Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
• B.A./B.S. required with strong emphasis in science and/or biology.

Extent of Travel:

• Expected travelling ~2-3 days/week.
• Ability to travel domestically and internationally approximately 65%-75% of working time.
• Current driver’s license preferred.

MRLGCTO

#EligibleforERP

ETJOBS

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

EEOC GINA Supplement

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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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:

$72,880.00 - $114,600.00

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:

Remote Work

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

na

Requisition ID:R253709