Clinical Research Specialist ACM
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Job Location:
Denver, CO - USA
Monthly Salary:
$ 83200 - 124800
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
In this exciting role as a Clinical research Specialist you will have primary responsibility to manage day-to-day study operations within the Medtronic Clinical Physiology Lab. This is a Research Specialist role reporting to the Clinical Lab Manager. The Clinical Research Specialist will independently develop and maintain clinical study documentation including developing clinical investigation plans case report forms IRB submissions trail master files SOPs and additional plans and documents as needed.The Clinical research Specialist will facilitate and maintain clinical study databases and assist with the drafting distribution and tracking of study paperwork and informed consents. Additionally the CRS role is expected to assist in the laboratory and clinical study operations through study execution recruitment and scheduling and maintenance of procedures in one or more of the following areas: production research and development quality control/assurance and/or compliance/environmental safety.
Location:Denver CO
Travelup to 15% (primarily domestic and occasionally international).
Operating Unit
The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery innovation and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.ACM is a $2B global business focused on airway management and patient monitoring technologies.
We believe that when people from different cultures genders and points of view come together innovation is the result and everyone wins. Medtronic walks the walk creating an inclusive culture where you can thrive.
Our space the medical device and healthcare industry is rapidly changing. It always has been that way. With remote monitoring wearables robotics AR/VR telemedicine and much more agility and responsiveness are key to our success. Experience what its like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.
Develop draft and maintain clinical study documentation
Execute study protocols in the lab
Develop draft and maintain accessory plans for clinical studies
Establish and maintain regular communication with research management and product managers
Enter data and maintain database of subject demographic information.
Conduct laboratory support functions such as ordering stocking and distributing supplies and equipment and collecting washing and storing equipment.
Maintain organizational standards: GCP GLP CITI training.
Prepare and maintain general laboratory quality controls and appropriate auditable documentation
Collaborate in study conduct and study subject communication interactions and ensure confidentiality.
Data coordination- actively participate in the development and testing of case report forms study reports and study databases based on protocol requirements.
Ensure timely and quality completion of data forms verify study data and generate manage and resolve data discrepancies.
May process compensation & identify and resolve compensation discrepancies.
Document coordination - create and manage clinical study files and oversee the organization and distribution of clinical study documents.
Assist with periodic audits of clinical study files for completeness and accuracy.
Additional tasks as assigned
Qualifications - External
Must Have: Minimum Requirements
Requires a Baccalaureate degree and minimum of 2 years of relevant experience or advanced degree with 0 years of experience.
Nice to Have
Experience in pre-market/ investigational and post market studies
Experience with database management subject recruitment and consenting data collection and clinical reporting.
Knowledge and familiarity with the operations of a medical research laboratory
Ability to follow established guidelines/procedures for the preparation of various administrative forms as well as learn new tasks independently.
Able to read and interpret technical procedures and regulatory requirements.
Experience in medical device clinical product trials and governing regulations.
Expertise withGood Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial.
Leadership skills include strong communication sense of urgency high accountability problem solving quality focus business integration acumen and change management.
Demonstrated ability to work effectively on cross-functional teams.
Experience in a high-demand and fast-paced environment.
Strong problem-solving skills.
Community outreach capabilities
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Spss
- Data Collection
- Genetics
- R
- Research Experience
- Statistical Software
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
