Merck & Co Hiring for Senior Clinical Research Associate- OH, MI, IL,IN (Remote) job in Rahway Full Time

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a-country.-
Under the oversight of the CRA manager or CRD, the person ensures compliance of study-conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality-standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new-sites. Participates in internal meetings and workstreams as SME for monitoring processes and-systems.

Responsibilities include, but are not limited to:-

• 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:

o Data generated at site are complete, accurate and unbiased.
o 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 internally 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 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.
• Following the country strategy defined by CRD and 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.
• Could perform Quality control visits if delegated by other roles and trained appropriately.

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 (Must have in certain countries).

Qualifications, Skills-& Experience-
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 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 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, also in a virtual-environment.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.

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.
• 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.

Experience Requirements:
Required:
– Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.-

Educational Requirements:
Preferred:
– B.A./B.S. with strong emphasis in science and/or biology.

MRLGCTO

#EligibleforERP

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Expected salary range:
$122,800.00 – $193,300.00

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 .

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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:
No

Hazardous Material(s):
NA

Requisition ID:R282957