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.
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 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 Clinical Research Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager and Regional Clinical Project Manager.
Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.
Contributes strongly to Clinical Research Associate 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.
Mentors / buddies junior Clinical Research Associates on process/study requirements and performs co-monitoring visits where appropriate
Education and Experience:
B.A./B.S. preferred with strong emphasis in science and/or biology
Minimum of 4 years of direct site management (monitoring) experience in a bio/pharma./ Clinical Research Organization.
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling 2-3 days/week.
Current driver's license preferred.
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
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
Merck is at the forefront of inventing tools for the fight against some of the world’s most urgent global health challenges. This includes more than 30 different cancers, hepatitis C, Alzheimer’s disease, Ebola, antibiotic-resistant "superbugs," cardio-metabolic diseases, and many others.
Since our inception in 1891, Merck has pushed the boundaries of science with the hope and expectation that advancing scientific knowledge will lead to major advances in health. Merck has changed the world repeatedly through our history – from the development of the first vaccines for measles and mumps and the first vaccine for HPV that causes cervical and other cancers, to the development of ground-breaking medicines for heart disease, osteoporosis, diabetes, tuberculosis, HIV and melanoma, just to name a few.