Merck Associate Clinical Research Associate – Florida (Remote) in Trenton, New Jersey

Job Description


Job Description

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.

  • Performs 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 & 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 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 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

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

  • Supports audit/inspection activities as needed.

  • Performs co-monitoring where appropriate.

Extent of Travel

  • Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.

  • Current driver’s license preferred.

Qualifications, Skills & Experience

Education Minimum Requirement:

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

  • Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

Competency Expectations:

  • 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.

  • Spanish speaking skills preferred.

  • 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 CRA 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.

  • Works with high quality and compliance mindset.

  • Capable of managing complex issues, solution-oriented approach.

  • Ability to perform root cause analysis and implement preventative and corrective action.

Behavioral Competency Expectations:

  • 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, with support from Line Manager.

  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

  • Demonstrates commitment to Customer focus.

  • 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

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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, 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:

$75,400.00 – $118,700.00

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 (https://www.benefitsatmerck.com/) .

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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

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

NA

Job Posting End Date:

05/24/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R295713









Location

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