Clinical research associate jobs in Eagan, MN - 74 jobs

Job Title: Associate Clinical Research Specialist Duration: 24 Months Pay Rate: $35 - $38/hr on W2 The Associate Clinical Research Specialist (Clinical Safety) supports the management of clinical study safety data and potential complaint reporting to ensure compliance with regulatory and internal requirements. This role partners with cross-functional teams to manage adverse event reporting, device deficiencies, and safety documentation throughout the clinical study lifecycle. Must-Have Skills: Science, nursing, or medical background Experience with clinical databases (e.g., RAVE, Veeva Vault) Strong written and verbal communication skills Ability to review and assess clinical safety data (AEs/SAEs) Knowledge of clinical research regulations and compliance Key Responsibilities: Review and assess Adverse Events (AEs), Serious Adverse Events (SAEs), and device deficiencies Identify potential complaints and unreported safety events from CRFs Collaborate with Regulatory Affairs and complaint teams for timely safety reporting Communicate with clinical sites and monitors for follow-up information Support safety documentation, reports, and audits Experience & Education: Bachelor's degree required 0-5 years of clinical research or safety experience 40 hours/week

Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'. Job Description Position Description: The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Position Responsibilities: • Prepare and revise study materials and/or training • Conduct training of site and/or Medtronic staff • Assist in site initiation activities (e.g. study start-up documentation preparation) • Set-up and maintain accurate progress and study status tracking logs • Assist in the preparation of reports, regulatory submissions, publications and presentations • Assist in the preparation of budgets and project plans • Identify and mitigate quality risk and/or issues associated with assigned studies/activities • May arrange conference calls, staff meetings, and training events. • Assist in the preparation and review of data • Oversee follow-up and resolution of sites issues • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks • Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications Basic Qualifications: • Bachelors degree • 4+ years' experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies • Proficient knowledge of medical terminology Additional Information If you are interested and want to apply, please contact: Ebrahim Sayarwala ebrahim.sayarwala(at )collabera.com ************

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Title: Senior Clinical Research Monitor Location: Mounds View, MN Duration: 24+ (possibility of extension) MANDAOTORY REQUIRED 1) Device experience 2) Cardiovascular experience There is a total of 3 openings and they need 1 candidate in each region below: Region 1 (NorthEast), Region 4 or 5 (Midwest) and Region 6 (West Coast). POSITION DESCRIPTION: · The Senior Clinical Research Monitor is responsible for the ov ersight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements. · This position works under minimal supervision, working closely with study teams, site personnel, and Healthcare field personnel and monitoring supervisor for resolution of site issues. · The Senior Clinical Research Monitor may play a leadership role in managing monitoring activities. · POSITION RESPONSIBILITIES: • Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines and policies • Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up • Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan • Identify site needs, provide solutions to facilitate the clinical trial process • Act as a primary point of contact for study sites as requested • Provide input into the development and improvement of investigator and site management systems (e.g., CTMS) • Assist in initial and ongoing site personnel training as required • Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures • Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance. • Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.) • Possess a working knowledge of disease state and investigational product • Possess understanding of regulatory requirements • Mentor and/or train junior personnel • Assist sites/study teams with audit preparation • Adhere to all applicable Healthcare policies and procedures In addition, the Senior Clinical Research Monitor may: • Attend Investigator and/or Coordinator meetings • Prepare meeting presentations and/or deliver training during meetings (Investigator/Coordinator meetings, study/monitoring team meetings, etc.) • Provide input into final study site selection • Be involved in site management activities • Be assigned lead monitor responsibilities which include but are not limited to: o Providing input on study protocol, CRFs and other study documents o Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets o Assisting in the creation of corrective and preventive action plans and trending reports o Managing site assignments in collaboration with manager o Facilitating communication and information flow between assigned project teams and assigned monitors on project o Ensuring monitors are trained, current with project requirements and understand study milestones o Overseeing action item tracking and resolution status o Performing co-monitoring visits as needed o Ensuring Monitoring Plan requirements are being met and escalates risks o Attending Core/Study team meetings BASIC QUALIFICATIONS: Education Required: · Bachelor's Degree in life sciences , nursing or other health related disciplines Years Of Experience: · Four (4) years clinical research experience with at least two (2) years of clinical monitoring experience or Master's degree with 2 years clinical research experience DESIRED/PREFERRED QUALIFICATIONS • Cardiovascular experience • Experience monitor Device Trials • Excellent interpersonal skills • Experience working in a team/matrix environment requiring strong working relationships • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously • Ability to work in a fast paced environment • Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. • High attention to detail and accuracy • Experience working independently in a regional area with remote or minimal supervision • Strong leadership skills • Excellent problem solving skills • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel ) • Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.) • Business knowledge or experience with the medical / healthcare industry • Class III medical device and/or phase II, III and IV pharmaceutical experience • Experience to demonstrate understanding of technical, scientific and medical information • Experience with Regulatory and Quality Assurance audits • Experience of conducting clinical research activities in a regulated environment • Proficient knowledge of medical terminology • Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable) • Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training) PHYSICAL JOB REQUIREMENTS: • 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. • 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. • Ability to travel up to 80% • Travel with colleagues and manager as requested • May require international travel Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do have referral bonus, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724 | LinkedIn: https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Job Description About the role: The Senior Clinical Research Specialist will join the Urology Biostatistics and Real World Evidence team. This role supports key commercialized products by developing and executing clinical research activities from real-world data sources and driving long-term evidence strategies. This role creates and maintains all documentation pertaining to clinical research activities, designs studies utilizing these non-clinical trial data sources, builds cohorts through data element identification and mapping, and collaborates cross-functionally to ensure cohesiveness and appropriateness of research scope. Responsibilities will include: Support strategic growth of the team's Real-World Evidence (RWE) capabilities and demonstrate ROI in the use of these new clinical data sources Plan and execute feasibility and analysis of the Urology RWE studies programmatically utilizing data science techniques and contribute to post-market documentation, publications, and other documents as needed. Design studies utilizing administrative claims, Electronic Health Records (EHR), and other RWE data sources by applying clinical research methodologies (e.g., research question development, population inclusion/exclusion, reduction of bias, etc.) Develop coding definitions utilizing reimbursement code sets (ICD-10-CM, ICD-10-PCS, CPT, etc.) and medical terminologies (SNOMED, LOINC, RxNorm, etc.) for populations, outcomes, and co-variates of interest in the Urology space. Collaborate cross-functionally with Clinical Strategy, Scientific Communication, Biostatistics, Medical Safety, Legal, and Compliance to design and run RWE studies. Manage internal and external project materials and timelines. Participate as a key team member on process development and improvement efforts to meet Urology VIP goals. Required Qualifications: Minimum of a Bachelor's Degree in a related field and 4 years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) or advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 4+ years of related work experience Expertise in leveraging medical coding systems and terminologies for research applications (ICD-9/10, CPT, SNOMED, LOINC, RxNorm, etc.) Proven experience using Python, R, other software for exploring, structuring, and analyzing data sets, relational data modeling and querying expertise (SQL) Ability to work in a team environment and possess clear, concise communication skills - both written and verbal Preferred Qualifications: Preferred medical device or clinical experience in Urology Prior or current experience in retrospective research design with Real World data including claims data inclusive of Charge Master Data and/or Electronic Health Record (EHR) data Proven scientific writing experience Proven Physician-facing experience

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. * Assists Study Directors on select projects under the direction and review of the Study Director team. * Assists in collection, documentation and analysis of pre-clinical data. * Assists in the coordination of study tasks from pre-study initiation to study completion. * Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. * Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. * Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. * Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. * Assists with data collection, database entry and generating/tabulating data. * Distributes study related documents, i.e. copies of study data sheets * Creates documentation per SOP to assist with test/control article accountability. * May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. * Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. * Maintains client inventory and is required to be familiar with internal and competitor products. * Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. * Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. * Serves as the Study Coordinator for GLP and non-GLP preclinical studies and supports the Study Director for non-clinical projects. * Assists Study Directors prior, during and post-study by coordinating scientific, administrative, and logistic support for studies. * Creates and manages the use and distribution of study related documents, i.e. copies of study data sheets, IACUC information sheets, and study progress tracking documentation. * Supports semi-moderately complex studies and supports the Study Director keeping the team informed of scheduling needs and any unforeseen events or issues. * Other duties as assigned. Qualifications & Technical Competencies: * Requires a Bachelor's degree (BS/BA) or equivalent in a scientific discipline and 0 - 2 years of related laboratory experience * OR - * At least 5 years of laboratory experience without a Bachelor's degree * Equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above. Working Conditions: * While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. * The noise level in the work environment is usually moderate. * While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. * Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $21.25 Pay Range Target: $26.00 Pay Frequency: Hourly Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinical research. We are seeking a highly motivated individual to oversee, design, and develop clinical evaluation research studies. This role offers the opportunity to work full-time on-site in a collaborative and cutting-edge environment. Must Have Experience with CTMS and patient data and site management systems (i.E., Veeva Vault, RAD Rave, Oracle) Proficiency in Microsoft Office Applications Top 3 Candidate Experience Requirements Site management experience (site or sponsor) Knowledge/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Education and Experience Education Required: Bachelor's Degree (preferably in engineering, life sciences, or related medical/scientific field) Years of Experience Required: Minimum 2 years of experience Responsibilities Responsibilities may include the following and other duties may be assigned: Oversee, design, plan, and develop clinical evaluation research studies. Prepare and author protocols and patient record forms. Conduct registered and nonregistered clinical studies of products that satisfy a medical need and/or offer commercial potential. Oversee and interpret results of clinical investigations in preparation for new drug device or consumer applications. Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection. Career Stream This position typically involves responsibilities in a professional discipline or specialty. The role requires delivering and/or managing projects assigned and collaborating with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of other lower-level professionals. Required Knowledge and Experience The position requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with 0 years of experience.

Join us as a Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity. What You'll Do: • Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines. • Provide medical care to patients, always ensuring patient safety comes first. • Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized. • Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). • Record all patient information and results from tests as per protocol on required forms. • Where required, may complete IP accountability logs and associated information. • Reports suspected non-compliance with relevant site staff. • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. • Promotes the company and builds a positive relationship with patients to ensure retention. • Attend site initiation meetings and all other relevant meetings to receive training on protocol. • May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results. • Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. • Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded. • Adhere to company COP/SCOP. • May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • BLS certificate required. • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) • Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving • Demonstrated ability to exercise discretion and sound judgement • Good decision-making, negotiation and influencing skills • Good communication skills and English fluency will be an advantage • Good organizational skills • Good proficiency in basic computer applications • Good interpersonal skills to work in a team environment Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment is required such as protective eyewear, garments and gloves. • Occasional travel may be domestic or international. Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthrough. Compensation and Benefits The hourly pay range estimated for this position based in Minnesota is $26.00-$30.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

* Candidates must be a Minnesota resident. Job Status: Full-time (Monday - Friday) We are seeking a motivated and talented Clinical Research Coordinator to join our busy, fast paced specialty office at Twin Cities Spine Center (TC Spine). Come be a part in our patient's lives and work for an organization that has consistently been named one of the area's Top Workplaces. The Research Coordinator is a critical role responsible for managing the activities of ongoing research projects and studies that support Twin Cities Spine Center's (TC Spine) research and fellowship programs. Working closely with the Research Director and staff, Surgeon Investigators, and Fellows, this role assists with the development of research studies and is responsible for managing multiple research projects. The Research Coordinator duties include study material preparation, data management, regulatory document preparation, and project coordination in accordance with established protocols, federal and state regulations, and Institutional Review Board (IRB) requirements. The Research Coordinator also plays a key role in scholarly activity by co-authoring abstracts and manuscripts for submission to conferences and peer-reviewed medical journals. In addition, this role manages research and quality data that supports organizational Quality Assurance and continuous improvement initiatives. Job Responsibilities: * Co-author and submit abstracts and manuscripts to conferences and peer-reviewed medical journals * Develop and write research protocols, informed consent forms, grants, and other study related documents * Prepare and submit Institutional Review Board (IRB) documentation (initial approvals, continuing reviews, adverse event reports, and study closure reports) * Maintain regulatory binders, source documentation and appropriate forms per protocol * Perform data abstraction for research studies * Ensure the accuracy, completeness, and integrity of data * Maintain research database including validity and consistency assessments * Learn and implement new technology and software for research (e.g., Outcomes Based Electronic Research Database - OBERD) * Plan project timelines, milestones and deliverables, then implement and track project progress * Communicate project status to the Research Director, surgeon investigators and Fellows (study advances or delays with approvals, data collection, patient enrollment, etc.) * Maintain regular communication with study participants and address any concerns * Ensure research studies are conducted ethically and in compliance with Federal and state laws * Respect and protect confidentiality of subjects (HIPAA) * Screen and enroll study participants (obtain and document Informed Consent) * Develop and implement strategies for participant recruitment and retention * Attend weekly Monday conferences in-person * Work with the other Research Coordinators, the Research Director, surgeon investigators, and Fellows to ensure projects are completed Job Requirements: * Master of Science or Arts Degree or higher, required * Requires a minimum of 5 years' experience in clinical research * Proficient with healthcare software (Epic, NextGen) for research purposes * Proficient with IRB processes and compliance rules pertaining to research, confidentiality, and HIPAA * Working knowledge of US Food and Drug Administration (FDA) and state laws and regulations pertaining to clinical trials * Advanced knowledge of Microsoft Office Suite * Ability to adapt to different working styles and effectively communicate with staff and providers using excellent interpersonal and verbal/written communication skills * Ability to pay attention to the smallest details involved in taking service to the next level to deliver high-quality customer service to external/internal customers and communicate with knowledge and compassion * Ability to effectively manage and prioritize multiple tasks, frequent interruptions, and details with accuracy * Ability to resolve basic service recovery issues and understand when to escalate to the next level * Ability to work with people of all ages, ethnicities, and backgrounds Benefits: * Medical, Dental, and Vision Insurance * Group Life and AD&D coverage * Company Paid Short and Long Term Disability coverage * Flexible Spending and Health Saving Account options * 401(k) plan through salary deferrals * PTO and Paid Holidays The above description is intended to provide a general outline of some of the basic job requirements and responsibilities and is not all inclusive. Job responsibilities, required skills, and working conditions are also subject to change from time to time. Twin Cities Spine Center is an Equal Employment Opportunity Employer, and provides reasonable accommodation to qualified disabled individuals in accordance with applicable federal and state law.

The Clinical Research Coordinator (CRC) assists with the planning, development, and execution of high-quality clinical activities. This role is ideal for someone with an interest in learning and developing skills in clinical research, research methodology, regulations, and applicable guidelines including FDA regulations, international regulatory standards, Good Clinical Practice (GCP), ISO compliance, and company SOPs. The CRC role supports the broader clinical operations team by coordinating study activities and maintaining documentation standards. The CRC must demonstrate strong organizational skills, attention to detail, and the ability to produce high-quality work under tight timelines. The CRC collaborates with the internal team, contract research organizations (CROs), study personnel, and other vendors throughout the execution of clinical trials. This is an entry-level position perfect for someone eager to build a strong foundation in clinical research. Principal Responsibilities: Support clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation, site management, data management and other ongoing tasks to support clinical trials Perform study related activities in compliance with GCP and FDA regulations for clinical trials Contribute to the formatting of study documents and manage the upload and tracking of clinical documents into the Quality Management System (QMS) Ensure ordering of clinical study supplies when needed Assemble and distribute study related documents including regulatory binders, case report form binders, study manuals, retention initiatives, and other study related tools to sites Creation and maintenance of study trackers, dashboards, and reports Support clinical study payments, where applicable Participate in study-specific meetings, record meeting minutes including issues and actions items; and file minutes accordingly Manage and track the electronic (and/or paper) study site and master files, ensuring audit readiness Create and distribute study specific newsletters to the clinical sites Provide travel and logistical support to physician proctors and clinical team as needed Support the planning and conduct of investigator/study meetings Ensure proper handling, accountability, and reconciliation of all Investigational Product (IP) Assist with clinicaltrials.gov updates Complete Central IRB submissions Complete submission to the QMS Organize and manage the Clinical Site email inbox Facilitate licensing agreements with respective vendors Facilitate document translations with respective vendors Develop and maintain successful working relationships, manage deliverables, and provide feedback to cross functional team members. Qualifications, Education & Experience: Must Have: Excellent organizational skills Excellent interpersonal, written, and verbal communication skills Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels Ability to multitask effectively while maintaining high quality outputs Nice to Have: Proven experience working within an FDA IDE pre-market clinical studies, post-market studies or registries Strong knowledge and understanding of prostate anatomy Working Conditions: Occasionally exerting up to 20lbs and lifting to 50lbs Significant work pace and pressure due to deadlines of a start-up organization Operate a computer, and other office equipment, proficient in Microsoft Office software Travel may be required (up to 5%,); to assist with the logistics of Investigator and Research Coordinator meetings Position based in Maple Grove, MN

Job Description Apply Here: ******************************************************************************** We are seeking multiple outgoing, patient focused individuals to work as Clinical Trials Research Assistant at our Retina Consultants of Minnesota Edina, MN clinic.Responsibilities for an Clinical Trials Research Assistant include: Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Observe Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy) Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Process and ship laboratory biological samples for analysis Perform intraocular pressure checks after injections Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites) Inform subjects and obtain written re-consents in regard to ICF's Required Skills, Abilities and Attributes: Applicants MUST be personally motivated to provide excellent patient care! 1+ years of clinical trials research assistant experience in a retina or general ophthalmology environment preferred Knowledge of medical terminology Be an excellent team player who works cooperatively and respectfully with all doctors, supervisors and co-workers Displays a desire to perpetually “Learn and Grow” Efficient and highly accurate user of applicable information technology and health care management systems High School Degree or GED We offer excellent compensation and benefits, to include: Paid Holidays - 7 days per year Personal Time Off (PTO) - 16 days per year Health Insurance Health Reimbursement Account Health Savings Account Dental Insurance (free single coverage) Flexible Spending Accounts Basic and Supplemental Term Life Insurance (free single coverage) Long Term Disability (free single coverage) Long Term Care (free single coverage) Short-Term Disability Vision Annual $250 uniform (scrubs and shoes) reimbursement About Retina Consultants of Minnesota (RCM):RCM has 9 Minnesota locations - St. Louis Park, Edina, Edina Specialty, Woodbury, Blaine, Duluth, Maplewood, Anoka and Mankato.Everything we do…. every decision we make…takes our Guiding Principles into consideration. Our guiding principles are: We exist to serve our patients. We will provide the best available medical skills, technology, and service. We will be their advocates. We will care for our patients as if they were members of our family. We will treat our patients with respect, dignity, and kindness. We are proud of our dedicated staff. We will strive to provide a rewarding career with opportunity for personal and professional growth. We will promote teamwork. We will provide a respectful and safe working environment. We are humbled that other doctors entrust their patients to our care. We will be available when we are needed. We will promptly communicate the results of patient evaluation and treatment. We will respect the referring doctors' relationships with their patients. We recognize that we have a responsibility to our community. We will strive to be desire to perpetually “Learn and Grow” Efficient and highly accurate user of applicable information technology and health care management systems A good corporate citizen. We will function ethically. We will be prudent in our stewardship of healthcare resources. Medical advances are critical to our patients. We will remain at the forefront in the search for new knowledge and treatments of retinal disease. We will participate in clinical research. We will share our knowledge with our patients and referring doctors, and with our retinal colleagues around the world.

Job Description Job Title: Clinical Research Assistant II (CRA II) Job Code: CRAII, Full Time, Benefit Eligible, Non-Exempt Lead Worker: Diana Burgess Admin Supervisor: Lee Cross Project: Reaching Rural Veterans: Applying Mind-Body Skills for Pain using a Whole Health Telehealth Intervention (RAMP) Summary: The Center for Veterans Research and Education (CVRE), whose mission is to help support innovative research and education initiatives that improve the health and well-being of Veterans, is seeking a Clinical Research Assistant II. Position Description: The Clinical Research Assistant II is responsible for assisting the Principal Investigator with the conduct of preparatory work, recruitment of and follow-up with study participants for the RAMP study. This will involve 9 facilitated group sessions including education and training in different tools and strategies. Responsibilities: Major duties and responsibilities include, but are not limited to the following: Preparing and emailing/mailing recruitment and randomization materials Preparing research participant and advisor payment materials Logging returned assessments Making follow-up phone calls to Veterans Answering Veteran questions via email and phone Conducting health assessments and research questionnaires by telephone Responding to identified suicide risk by following the safety procedures and informing the study Principal Investigators and Project Director Assisting in data collection/cleaning Maintaining data and study files in accordance with project protocols Scheduling study related meetings and keeping minutes documenting decisions Alerting the Principal Investigators and Project Director of data collection/protocol breeches, inconsistencies, or other problems that may arise within the study, as well as suggesting methods of correction Assisting in the preparation of manuscripts and presentation of the data. Activities may include helping to create posters for professional presentations; creating tables and charts; editing scholarly manuscripts; and assisting with formatting and uploading files, etc. Other duties as assigned Applicant must include a cover letter Minimum Qualifications: Education: Bachelor's (BA/BS) or above from an accredited college or university in public health, sociology, psychology, or related allied health field Experience: 1-3 years of experience required for CRA II or a post-graduate degree. Licensure/Registration/Certification: None Preferred Qualifications: Minimum 1 year of Clinical Research Assistant experience dealing with data collection and data storage, human subject studies, and institutional review board processes preferred. Knowledge, Skills, and Abilities: Basic experience with trouble-shooting devices and software settings. Experience in coordinating multiple task and project elements with differing timelines and completion deadlines. Demonstrated ability to work effectively both independently and as part of a team. Excellent oral and written communication skills. Exceptional attention to detail and organizational skills. Proficiency in Microsoft Office products including Outlook, Word, PowerPoint, and Excel. Knowledge of Good Clinical Practices, human subjects' protection, and federal regulations related to clinical research. Conditions of Employment: Subject to a criminal and educational background check. Designated and/or random drug testing may be required. Regular and predictable attendance is required. Typical hours fall within standard business hours, work may be required during hours beyond standard business hours, including weekends. Must be a US citizen Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and lift 25 lbs. Reasonable accommodation may be considered in determining an applicant's ability to perform the duties/functions of the position. Equal Employment Opportunity: Center for Veterans Research and Education does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy), gender identity or status as transgender, national origin, caste, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor protected by federal, state or local law.

Full Time Home Health Clinical Coordinator Are you a professional looking to grow your career in Home Health? Accurate Home care is looking to expand their Home Health team with a Clinical Coordinator. Who are we? At Accurate Home Care, our Home Health team aids in empowering our patients to stay at home and recover. This strong team of home health professionals manages the care of our patients while building relationships and ensuring a positive patient experience. The Clinical Coordinator plays a key role in supporting the care team. What's in it for me? Location: Otsego Office Hours/days: Monday- Friday 8am-5pm Pay rate starting at $20-25/hour Benefits: generous health insurance reimbursement plan, 401k match, paid time off, What else? build relationships with care providers, work in a fast-paced environment and grow your knowledge of home health. What will I be doing? Assist with coordination of the patient referral/intake process Communicate with nursing care team and physician offices Organize multiple facets of care delivery including scheduling, communication, and management of patient medical record. Qualifications What do I need to bring to the job? Valid license as a Licensed Practical Nurse in the state of Minnesota is preferred but not required. Working knowledge of Microsoft Office Suite Excellent oral and written communication skills, in the English language Two years of home care experience preferred

Saint Therese is a nonprofit faith-based organization that has focused on the well-being of individuals since it opened in 1968. We provide secure, stress-free living and the very best in senior care and housing with a commitment to each individual. Saint Therese offers a full continuum of programs and services that are available in your own home or in one of our community settings. Saint Therese serves the Twin Cities metro area with campuses located in New Hope, Brooklyn Park, Shoreview and Woodbury. Saint Therese Oxbow Lake in Brooklyn Park, a long term care facility and independent living center for seniors has an opening for a Plant Operations Director. Saint Therese offers a wide variety of employee benefits, tuition reimbursement and flexible scheduling! Job Description Has responsibility for managing/ensuring quality care for Residents and provides ongoing customer service to families. Mentors staff in providing care and maintains compliance with government regulations has overall responsibility for the clinical management of the patients. Understands the concept of and is committed to the mission of St. Therese. Implements a plan of care of each resident assigned. Assures that the integrity of the nursing practice of the nurses under his/her supervision is in compliance with the Minnesota Board of Nursing, Nurse Practice Act and standards of care. Maintains open lines of communication with residents, staff, families, volunteers and visitors. Qualifications Education: Registered Nurse with certification as a Geriatric Nurse desired. Experience: At least three years of experience in a nursing home as a registered nurse preferred. MDS experience is preferred, but is not required. Additional Information CHECK OUT OUR WEBSITE FOR OTHER POTENTIAL OPEN POSITIONS! *********************************** All your information will be kept confidential according to EEO guidelines. Please submit application online at ***********************************searchjobs.php Apply directly at ******************* To view our website for more information on Saint Therese http://*******************/

Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'. Job Description Position Description: The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Position Responsibilities: • Prepare and revise study materials and/or training • Conduct training of site and/or Medtronic staff • Assist in site initiation activities (e.g. study start-up documentation preparation) • Set-up and maintain accurate progress and study status tracking logs • Assist in the preparation of reports, regulatory submissions, publications and presentations • Assist in the preparation of budgets and project plans • Identify and mitigate quality risk and/or issues associated with assigned studies/activities • May arrange conference calls, staff meetings, and training events. • Assist in the preparation and review of data • Oversee follow-up and resolution of sites issues • Oversee activities performed by extended team members including work direction (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines • Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks • Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications Basic Qualifications: • Bachelors degree • 4+ years' experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies • Proficient knowledge of medical terminology Additional Information If you are interested and want to apply, please contact: Ebrahim Sayarwala ********************************** ************

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Title: Senior Clinical Research Monitor Location: Mounds View, MN Duration: 24+ (possibility of extension) MANDAOTORY REQUIRED 1) Device experience 2) Cardiovascular experience There is a total of 3 openings and they need 1 candidate in each region below: Region 1 (NorthEast), Region 4 or 5 (Midwest) and Region 6 (West Coast). POSITION DESCRIPTION: · The Senior Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements. · This position works under minimal supervision, working closely with study teams, site personnel, and Healthcare field personnel and monitoring supervisor for resolution of site issues. · The Senior Clinical Research Monitor may play a leadership role in managing monitoring activities. · POSITION RESPONSIBILITIES: • Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Healthcare standards, guidelines and policies • Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up • Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan • Identify site needs, provide solutions to facilitate the clinical trial process • Act as a primary point of contact for study sites as requested • Provide input into the development and improvement of investigator and site management systems (e.g., CTMS) • Assist in initial and ongoing site personnel training as required • Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures • Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance. • Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.) • Possess a working knowledge of disease state and investigational product • Possess understanding of regulatory requirements • Mentor and/or train junior personnel • Assist sites/study teams with audit preparation • Adhere to all applicable Healthcare policies and procedures In addition, the Senior Clinical Research Monitor may: • Attend Investigator and/or Coordinator meetings • Prepare meeting presentations and/or deliver training during meetings (Investigator/Coordinator meetings, study/monitoring team meetings, etc.) • Provide input into final study site selection • Be involved in site management activities • Be assigned lead monitor responsibilities which include but are not limited to: o Providing input on study protocol, CRFs and other study documents o Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets o Assisting in the creation of corrective and preventive action plans and trending reports o Managing site assignments in collaboration with manager o Facilitating communication and information flow between assigned project teams and assigned monitors on project o Ensuring monitors are trained, current with project requirements and understand study milestones o Overseeing action item tracking and resolution status o Performing co-monitoring visits as needed o Ensuring Monitoring Plan requirements are being met and escalates risks o Attending Core/Study team meetings BASIC QUALIFICATIONS: Education Required: · Bachelor's Degree in life sciences, nursing or other health related disciplines Years Of Experience: · Four (4) years clinical research experience with at least two (2) years of clinical monitoring experience or Master's degree with 2 years clinical research experience DESIRED/PREFERRED QUALIFICATIONS • Cardiovascular experience • Experience monitor Device Trials • Excellent interpersonal skills • Experience working in a team/matrix environment requiring strong working relationships • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously • Ability to work in a fast paced environment • Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. • High attention to detail and accuracy • Experience working independently in a regional area with remote or minimal supervision • Strong leadership skills • Excellent problem solving skills • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel) • Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.) • Business knowledge or experience with the medical / healthcare industry • Class III medical device and/or phase II, III and IV pharmaceutical experience • Experience to demonstrate understanding of technical, scientific and medical information • Experience with Regulatory and Quality Assurance audits • Experience of conducting clinical research activities in a regulated environment • Proficient knowledge of medical terminology • Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable) • Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training) PHYSICAL JOB REQUIREMENTS: • 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. • 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. • Ability to travel up to 80% • Travel with colleagues and manager as requested • May require international travel Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do have referral bonus, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724| LinkedIn: https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. • Assists Study Directors on select projects under the direction and review of the Study Director team. • Assists in collection, documentation and analysis of pre-clinical data. • Assists in the coordination of study tasks from pre-study initiation to study completion. • Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. • Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. • Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. • Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. • Assists with data collection, database entry and generating/tabulating data. • Distributes study related documents, i.e. copies of study data sheets • Creates documentation per SOP to assist with test/control article accountability. • May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. • Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. • Maintains client inventory and is required to be familiar with internal and competitor products. • Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. • Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. • Serves as the Study Coordinator for GLP and non-GLP preclinical studies and supports the Study Director for non-clinical projects. • Assists Study Directors prior, during and post-study by coordinating scientific, administrative, and logistic support for studies. • Creates and manages the use and distribution of study related documents, i.e. copies of study data sheets, IACUC information sheets, and study progress tracking documentation. • Supports semi-moderately complex studies and supports the Study Director keeping the team informed of scheduling needs and any unforeseen events or issues. • Other duties as assigned. Qualifications & Technical Competencies: • Requires a Bachelor's degree (BS/BA) or equivalent in a scientific discipline and 0 - 2 years of related laboratory experience - OR - • At least 5 years of laboratory experience without a Bachelor's degree • Equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above. Working Conditions: • While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. • The noise level in the work environment is usually moderate. • While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. • Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $21.25 Pay Range Target: $26.00 Pay Frequency: Hourly Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

*Candidates must be a Minnesota resident. Job Status: Full-time (Monday - Friday) We are seeking a motivated and talented Clinical Research Coordinator to join our busy, fast paced specialty office at Twin Cities Spine Center (TC Spine). Come be a part in our patient's lives and work for an organization that has consistently been named one of the area's Top Workplaces. The Research Coordinator is a critical role responsible for managing the activities of ongoing research projects and studies that support Twin Cities Spine Center's (TC Spine) research and fellowship programs. Working closely with the Research Director and staff, Surgeon Investigators, and Fellows, this role assists with the development of research studies and is responsible for managing multiple research projects. The Research Coordinator duties include study material preparation, data management, regulatory document preparation, and project coordination in accordance with established protocols, federal and state regulations, and Institutional Review Board (IRB) requirements. The Research Coordinator also plays a key role in scholarly activity by co-authoring abstracts and manuscripts for submission to conferences and peer-reviewed medical journals. In addition, this role manages research and quality data that supports organizational Quality Assurance and continuous improvement initiatives. Job Responsibilities: Co-author and submit abstracts and manuscripts to conferences and peer-reviewed medical journals Develop and write research protocols, informed consent forms, grants, and other study related documents Prepare and submit Institutional Review Board (IRB) documentation (initial approvals, continuing reviews, adverse event reports, and study closure reports) Maintain regulatory binders, source documentation and appropriate forms per protocol Perform data abstraction for research studies Ensure the accuracy, completeness, and integrity of data Maintain research database including validity and consistency assessments Learn and implement new technology and software for research (e.g., Outcomes Based Electronic Research Database - OBERD) Plan project timelines, milestones and deliverables, then implement and track project progress Communicate project status to the Research Director, surgeon investigators and Fellows (study advances or delays with approvals, data collection, patient enrollment, etc.) Maintain regular communication with study participants and address any concerns Ensure research studies are conducted ethically and in compliance with Federal and state laws Respect and protect confidentiality of subjects (HIPAA) Screen and enroll study participants (obtain and document Informed Consent) Develop and implement strategies for participant recruitment and retention Attend weekly Monday conferences in-person Work with the other Research Coordinators, the Research Director, surgeon investigators, and Fellows to ensure projects are completed Job Requirements: Master of Science or Arts Degree or higher, required Requires a minimum of 5 years' experience in clinical research Proficient with healthcare software (Epic, NextGen) for research purposes Proficient with IRB processes and compliance rules pertaining to research, confidentiality, and HIPAA Working knowledge of US Food and Drug Administration (FDA) and state laws and regulations pertaining to clinical trials Advanced knowledge of Microsoft Office Suite Ability to adapt to different working styles and effectively communicate with staff and providers using excellent interpersonal and verbal/written communication skills Ability to pay attention to the smallest details involved in taking service to the next level to deliver high-quality customer service to external/internal customers and communicate with knowledge and compassion Ability to effectively manage and prioritize multiple tasks, frequent interruptions, and details with accuracy Ability to resolve basic service recovery issues and understand when to escalate to the next level Ability to work with people of all ages, ethnicities, and backgrounds Benefits: Medical, Dental, and Vision Insurance Group Life and AD&D coverage Company Paid Short and Long Term Disability coverage Flexible Spending and Health Saving Account options 401(k) plan through salary deferrals PTO and Paid Holidays The above description is intended to provide a general outline of some of the basic job requirements and responsibilities and is not all inclusive. Job responsibilities, required skills, and working conditions are also subject to change from time to time. Twin Cities Spine Center is an Equal Employment Opportunity Employer, and provides reasonable accommodation to qualified disabled individuals in accordance with applicable federal and state law.

Saint Therese is a nonprofit faith-based organization that has focused on the well-being of individuals since it opened in 1968. We provide secure, stress-free living and the very best in senior care and housing with a commitment to each individual. Saint Therese offers a full continuum of programs and services that are available in your own home or in one of our community settings. Saint Therese serves the Twin Cities metro area with campuses located in New Hope, Brooklyn Park, Shoreview and Woodbury. Saint Therese Oxbow Lake in Brooklyn Park, a long term care facility and independent living center for seniors has an opening for a Plant Operations Director. Saint Therese offers a wide variety of employee benefits, tuition reimbursement and flexible scheduling! Job Description Has responsibility for managing/ensuring quality care for Residents and provides ongoing customer service to families. Mentors staff in providing care and maintains compliance with government regulations has overall responsibility for the clinical management of the patients. Understands the concept of and is committed to the mission of St. Therese. Implements a plan of care of each resident assigned. Assures that the integrity of the nursing practice of the nurses under his/her supervision is in compliance with the Minnesota Board of Nursing, Nurse Practice Act and standards of care. Maintains open lines of communication with residents, staff, families, volunteers and visitors. Qualifications Education: Registered Nurse with certification as a Geriatric Nurse desired. Experience: At least three years of experience in a nursing home as a registered nurse preferred. MDS experience is preferred, but is not required. Additional Information CHECK OUT OUR WEBSITE FOR OTHER POTENTIAL OPEN POSITIONS! *********************************** All your information will be kept confidential according to EEO guidelines. Please submit application online at ***********************************searchjobs.php Apply directly at ******************* To view our website for more information on Saint Therese http://*******************/

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. • Assists Study Directors on select projects under the direction and review of the Study Director team. • Assists in collection, documentation and analysis of pre-clinical data. • Assists in the coordination of study tasks from pre-study initiation to study completion. • Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. • Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. • Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. • Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. • Assists with data collection, database entry and generating/tabulating data. • Distributes study related documents, i.e. copies of study data sheets • Creates documentation per SOP to assist with test/control article accountability. • May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. • Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. • Maintains client inventory and is required to be familiar with internal and competitor products. • Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. • Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. • Other duties as assigned. Qualifications & Technical Competencies: • One year experience in an administrative position desirable, preferably with an emphasis in a laboratory setting. • Working knowledge of word processing and spreadsheet software. • Requires a minimum of an Associate degree, preferably in a scientific discipline. Working Conditions: • While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. • The noise level in the work environment is usually moderate. • While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. • Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $17.79 Pay Range Target: $26.00 Pay Frequency: Hourly Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.