Clinical Research Associate (CRA), Oncology- Massachusetts Job Boston United States,
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The CRA acts as primary site contact and site manager throughout all
phases of a clinical research study, taking overall responsibility of allocated
Duties and responsibilities include, but are not limited to the following:
- 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
- Coordinates & manages various tasks in collaboration
with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and
- 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 CRA Escalation Pathway as
appropriate in collaboration with CRM, PLM and RCPM.
- 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 process
Subject Matter Expert (SME), buddy/mentor and sharing best practices as
- Supports and/or leads audit/inspection
activities as needed
*This is a remote/Home-based position.
- Required: BA/BS
- Preferred: BA/BS with strong emphasis in science and/or biology
- Minimum of 2 years of direct site monitoring experience in a Biopharmaceutical, Pharmaceutical or CRO company.
- Experience monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc.
- Travel: 65%-75%
- Valid driver's license
CORE Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand 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
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 mindset
Our employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Research Monitor(CRA)
Job Title:Specialist, Clinical Research
Primary Location: NA-US-MA-Boston
Other Locations: NA-US-Massachusetts, NA-United States
Employee Status: Regular
Travel: Yes, 75 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Boston
Job Segment: Oncology, Clinic, Law, Research Associate, Clinical Research, Healthcare, Legal, Research
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