Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Core tasks, including but not limited to, the following:

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, 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 the 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 Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager, and Clinical Project Manager.

Manages and maintains information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.

Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor, and sharing best practices as appropriate/required.

Supports and/or leads audit/inspection activities as needed.

Mentor/train other Clinical Research Associate team members

Education and Experience:

B.A./B.S degree required; strong emphasis in science and/or biology preferred

Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma. / Clinical Research Organization.

Travel Expectations:

Ability to travel domestically and internationally approximately 65%-75% of working time.

Expected traveling 2-3 days/week.

The current driver's license required.

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 International Conference on Harmonization Good Clinical Practice (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 the 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

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

Works with high quality and compliance mindset

Demonstrates commitment to Customer focus