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About the Role

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

Responsibilities

Develops strong site relationships and ensures continuity 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates in and provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure data integrity and subject safety.
Conducts site visits (validation, initiation, monitoring, close-out) and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately and timely.
Collects, reviews, and monitors required regulatory documentation for study start-up, maintenance, and 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.
Works in partnership with various internal and external stakeholders to support assigned sites.
Manages and maintains information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
Contributes to CRA team knowledge by acting as a process Subject Matter Expert (SME), buddy/mentor, and sharing best practices.
Supports and/or leads audit/inspection activities as needed.
Performs co-monitoring visits where appropriate.
Contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Requirements

CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS: NEW YORK, NEW JERSEY, TEXAS, CHICAGO, SOUTHERN CALIFORNIA, MISSOURI
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
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.
Proven Skills in Site Management including 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.
Capable of managing complex issues, works in a solution-oriented manner.
Performs root cause analysis and implements preventative and corrective action.
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.
Current driver’s license required.

Skills

Accountability
Adaptability
Administrative Policies
Adverse Event Reporting System
Clinical Research Methods
Clinical Site Management
Clinical Study Management
Clinical Trial Planning
Clinical Trials
Clinical Trials Monitoring
Core Competencies
Data Analysis
Data Reporting
Early Clinical Development
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
IT Change Management
Oncology
Pharmacovigilance
Policy Development
Preventive Action
Protocol Adherence
Regulatory Affairs Compliance
Regulatory Compliance

Location

NEW YORK
NEW JERSEY
TEXAS
CHICAGO
SOUTHERN CALIFORNIA
MISSOURI

Work Type

Remote
Regular

Experience Level

At least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO (with Associate's degree, certificate or equivalent)
At least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO (with Bachelor’s degree or above)

Education Level

Associate's degree, certificate or equivalent in a scientific / healthcare discipline
Bachelor’s degree (or above)

Salary/Compensations

$96,200.00 - $151,400.00

Benefits

Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays, vacation, and compassionate and sick days
Annual bonus and long-term incentive, if applicable

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Equal Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
Learn more about your rights, including under California, Colorado and other US State Acts
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance