Clinical Research Associate *Pc 872

Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a division of the Miltenyi Biotec family focused on bringing customized cancer treatments and regenerative therapies to patients worldwide. Miltenyi Biomedicine serves an essential role in the Miltenyi Group, bridging the crucial divide from laboratory bench to patient bedside, ensuring that our innovations deliver direct benefits to those contending with some of today's most challenging diseases.

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Clinical Research Associate

Waltham, MA

Your Tasks:

Responsible for on-site and remote site monitoring activities for Miltenyi-sponsored clinical trials.

Essential Duties and Responsibilities:

• Monitor and ensure site compliance with the clinical protocol, company SOPs and ICH/GCP guidelines.
• Identify, assess, select, initiate and close-out appropriate clinical trials sites for Miltenyi-sponsored clinical trials.
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the conduct of the clinical trial.
• Train, support and motivate trial sites and investigators on conducting the trial.
• Facilitate subject enrollment at the site level with focused patient recruitment strategies and action plans.
• Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs).
• Facilitate the resolutions of clinical queries to investigative staff in accordance to the trial specific monitoring plan.
• Report protocol deviations and develop issue resolution plans.
• Review, collect and maintain essential documents required for clinical trial application.
• Writing visit reports and filing and collecting trial documentation and reports.
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings.
• Build and maintain solid and long-term professional relationships with investigators and site staff.
• Ensure timely communication of information between Clinical Development Department and site staff.
• Preparation, maintenance and archiving of TMF according to applicable SOPs and GCP.
• Actively participates as a member of the cross-functional project team; internally with the Departments of Clinical, Medical, Regulatory Affairs; externally with CROs and Miltenyi colleagues.

Requirements:

• Bachelor’s degree in Life Sciences or Medical Technology; 2-5+ years of clinical monitoring experience for industry-sponsored clinical trials; or equivalent combination of education and experience.
• Knowledge of Good Clinical Practices (GCP) required. Certification as a Clinical Research Associate or Clinical Research Professional such as CCRA or CCRP is highly desirable.
• Excellent planning, prioritization, attention to detail, and communication skills are required.
• Ability to operate a computer with Windows™ operating system, Outlook™ email, internet, databases, and basic MS Office™ products.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands and fingers, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, or crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit clinical trial sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs must be followed and PPE may be required to be worn per Miltenyi or hospital policies.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For more than 25 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 2,000 scientists, engineers, physicians, support specialists, marketers, and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biomedicine, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

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