- 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.
- 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 WindowsTM operating system, OutlookTM email, internet, databases, and basic MS OfficeTM products.
-
Research Associate
3 weeks ago
Forrester Cambridge, United StatesAt Forrester, we're trusted to work on trailblazing, mission critical problems that business and technology leaders face today. That's why we're always looking to empower talented individuals to perform at their best every single day. We're proud of our community of smart people ...
-
Research Associate
2 weeks ago
Charles River Laboratories Cambridge, United States**Req ID #**:222988**Location**:Cambridge, MA, US, For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-be ...
-
Research Associate
3 weeks ago
Pinetree Therapeutics Cambridge, United States**About the Company** · Pinetree Therapeutics, Inc. is a biotech startup developing bispecific antibodies for cancer therapy. Our mission is to deliver on the promise of therapeutic antibodies to treat drug resistant cancers and immune disorders and create the next generation of ...
-
Research Associate
1 week ago
Actalent Cambridge, United States Full timeDescription: · Independently, develop, optimize, and proactively troubleshoot cellular screening assays. · Responsible for generating, processing, interpreting, and presenting data in cross functional team meetings · Proactively employ cell and molecular biology techniques, inc ...
-
Research Associate
3 weeks ago
TechTrueUP Cambridge, United StatesBasic Qualifications · 0+ Years w/ Relevant BS OR equivalent 2+ Years w/ Relevant AS OR equivalent 4+ Years w/ HS Foundational knowledge of technical principles, theories, and concepts to perform routine work in a role · Top 3 Must Have Skill Sets: · MUST be willing to be onsite ...
-
Research Associate
2 weeks ago
Eurofins USA PSS Insourcing Solutions Cambridge, United States**Company Description** · Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, t ...
-
Research Associate
3 weeks ago
Generate Biomedicines Somerville, United States**About Generate:Biomedicines** · Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology to create breakthrough medicines where novel therapeutics are com ...
-
Research Associate
2 weeks ago
Point32Health Boston, United StatesWho We Are · Point32Health is a leading health and wellbeing organization, delivering an ever-better personalized health care experience to everyone in our communities. At Point32Health, we are building on the quality, nonprofit heritage of our founding organizations, Tufts Healt ...
-
Research Associate
2 weeks ago
Harvard University Boston, United States**Position Description**- **Primary Duties** · - Develop, design, conduct, analyze, and implement research using data science knowledge and prior knowledge of requested statistical packages. Perform statistical programming. · - Exercise independent decision making with regard to ...
-
Research Associate, Research
1 week ago
BioSpace Waltham, United StatesJob Details · Company · Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and e ...
-
Research Associate, Research
1 week ago
Visterra Waltham, United StatesJob Description · Job DescriptionSalary: · Company · Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology pl ...
-
Research Associate, Research
1 week ago
Visterra Inc. Waltham, United StatesCompany · Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of ...
-
Research Associate, Research
5 hours ago
Visterra Inc. Waltham, United StatesCompany · Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of ...
-
Associate Director Research
6 days ago
Sarepta Therapeutics Cambridge, United StatesThe Associate Director, R&CD Quality Assurance will be responsible for the delivery and execution of the Sarepta internal and external audit program, risk based audit plan development, and the conduct of GLP/GCP/GVP audits. The Associate Director will participate in vendor risk a ...
-
Research Associate, Research
1 week ago
Visterra Inc. Waltham, United StatesJob Description · Job Description Salary: · Company · Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology p ...
-
Research Associate, Biology
3 days ago
Wave Life Sciences Cambridge, United States**Description** · **Experience** · - BS/MS in biology, biochemistry, cellular/molecular biology, or related discipline with 1+ years of post-graduate research experience in an academic or industry setting · - PhD with 0+ years of post-graduate research experience will also be con ...
-
Research Associate Ii
3 weeks ago
Ultragenyx Pharmaceutical Woburn, United States**Why Join Us?** · - Be a hero for our rare disease patients_ · Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learnin ...
-
Research Associate
3 weeks ago
Meridian Bioscience, Inc. North Billerica, United StatesAbout Meridian: · Job Summary: · Primary role is to run experiments, acquire and record data. · Key Duties: · Tasks/Duties/Responsibilities: · - Support projects by conducting experiments, acquiring, and accurately documenting data. · - Contribute to completion of milestones asso ...
-
Research Associate
5 days ago
Mercy BioAnalytics Waltham, United StatesJoin the revolution in cancer early detection at Mercy Bio We're a pre-commercial biotechnology company on a mission to transform the future of healthcare by uncovering cancer's hidden biology. With a commitment to accessibility and equity, we're dedicated to making high performi ...
-
Associate Director, Research Finance
2 weeks ago
MIT Cambridge, United States**ASSOCIATE DIRECTOR, RESEARCH FINANCE**, _Office of the Vice President for Research (VPR)-Research Administration Services (RAS)_, to serve as the leader for research finance, providing sponsored research financial oversight, advice, and management on behalf of MIT-wide research ...
Clinical Research Associate PC 872 - Waltham, United States - Miltenyi Biotec
Description
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:
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
Miltenyi Biotec, Inc. participates in E-Verify.
