Clinical Research Associate

Job Description

Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through allphases 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 associateddocuments.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieveSite 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, monitoringvisits, close-out visits and records clear, comprehensive and accurate visit & non-visit contactreports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, studymaintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct,recruitment, retention, protocol deviations, regulatory documentation, site audits/inspectionsand overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems andescalates per defined CRA Escalation Pathway as appropriate in collaboration with CRAManager, 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 withvendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various othersystems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME),buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA manager, contributes to theidentification of new potential sites and works closely with them to develop strong clinicalresearch capabilities.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

CORE Competency Expectations:
• Fluent in Local Languages and English (verbal and written) and excellent communicationskills, 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 abilityto work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including management of site performance and patientrecruitment.
• 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, tabletand mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse 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.

Behavioural Competency Expectations:
• Effective time management, organizational and interpersonal skills, conflict management,problem solving skills.
• Demonstrated high level of monitoring skill with independent professional judgement.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple taskssimultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintainculturally 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 withorganizational policies and practices.

Experience Requirements:
Required:
• Min. 2 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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R316860