Clinical research coordinator jobs in Lakeville, MN

Job Title: Clinical Research Coordinator - Bilingual (EN/ES) Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Overview We are seeking a dedicated Clinical Research Coordinator to support all phases of clinical trials, from patient enrollment through study closeout. In this role, you will work closely with the Principal Investigator (PI) and cross-functional research teams to ensure high-quality study execution, strong patient support, and compliance with all regulatory requirements. This position is ideal for someone who thrives in a patient-focused environment. You will primarily support one site, allowing you to develop strong and meaningful relationships with the PI, study team, and patient population. Key Responsibilities Coordinate all aspects of clinical trials, including enrollment, study conduct, and closeout activities. Perform protocol-specific research procedures and support the PI throughout study execution. Serve as a liaison between investigators, sponsors, monitors, and internal study team members. Meet or exceed enrollment goals while ensuring high-quality, accurate, and timely data entry. Maintain strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all regulatory requirements. Foster a patient-centered environment, especially for rare disease populations with limited sample sizes. Support studies, including occasional early morning patient visits. Nice-to-Have Skills Prior experience in a clinical research setting. Phlebotomy experience is a plus. Strong organizational and multi-tasking abilities. Excellent communication and relationship-building skills. Must be bilingual in both English and Spanish. Soft Skills & Expectations Patient-focused, empathetic approach to clinical research. Strong interpersonal skills and the ability to collaborate effectively with diverse teams. Reliable follow-through and commitment to timely communication.

Clinical Research Spec Mounds View, MN- Local Onsite Lafayette, CO- Onsite Duration: 24 months+ (2 years) Shift: 1shift CST/MST Pay Range $40-$43/Hr on w2 Top 3 things required in a candidate's experience: Site management experience (site or sponsor) Knowledge/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Education Required: Bachelor Degree (prefer degree in engineering, life sciences, or related medical/scientific field) Years' Experience Required: Minimum 2 years experience Work Hours: Yes, 40 hours/week Work Location: Local to either of the MN locations or the CO location On-site Requirement: Yes, Full time on-site Must Have • Experience with CTMS and patient data and site management systems (i.e. Veeva Vault, RAD Rave, Oracle) • Experience with Microsoft Office Applications Responsibilities may include the following and other duties may be assigned: Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves 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, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site and vendor selection. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

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 ************

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

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: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * 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 talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual 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. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

Build Something Bigger - And Change Lives, Including Your Own. In 1935, Louise Whitbeck Fraser opened a school in her home for people with disabilities - defying social expectations and choosing compassion over convention. She believed everyone deserves the chance to reach their potential and thrive. Today, that same bold spirit is alive in every Fraser service. We're still building something bigger - a more inclusive, connected world where everyone belongs. At Fraser, you'll find more than a job. You'll find purpose. You'll find growth. And you'll find a place where your work changes lives - including your own. Fraser is seeking a Clinical Research Coordinator to serve as a scientific resource and supports Fraser research projects by coordinating activities, analyzing data, and communicating research findings to internal and external stakeholders regarding clinical outcomes in Specialty Healthcare. In addition,provide psychological assessment, intervention, and consultation for clients and families. Responsibilities: Scientific Resource: Manage and review study protocols/requests from internal and external stakeholders to assess relevance and resources available for such projects. Provide research reviews for staff requests that support the clinical operations of Fraser. Research Coordinator: Serve as Research consultant for staff examining clinical research. Under direction of Medical Director/Chief Clinical Officer identify primary projects that focus resources for collecting data, analyzing and communicating outcomes. Perform data collection, analysis, and reporting. Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency. Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices. Data Anlayst: Perform data collection, analysis, and reporting. Continuously audit database and identify issues of risk and process improvements to ensure accuracy and efficiency. Perform data collection interviews and data entry. Work in collaboration with Database Administrator to ensure successful integration of data collection and evaluation metrics into our electronic health record and practices. Psychologist: Participate in psychological testing for clients with social, behavioral, emotional, and developmental concerns. May deliver individual and family psychotherapy, including diagnostic assessments and treatment planning. May provide group therapy, for siblings, adults, parents, and children. Provide consultation and coordination of services with others involved with the client, such as the school, county, courts, biological family, foster parents. Schedule and provide clinical services and documentation in such a way as to meet or exceed budgeted client service hour targets. Requirements: MA, MS, Psy.D., Ph.D. in Psychology required, or other graduate degree with research experience that demonstrates understanding and skill for research activities. Current active Psychology licensure from the State of Minnesota. Training and experience in clinical research required. Valid Minnesota Driver's License with acceptable record. Commitment to promoting diversity, multiculturalism, and inclusion with a focus on culturally responsive practice, internal self-awareness, and reflection. Schedule, Location and Pay: Monday- Friday standard business hours .5 FTE Research Coordinator .5 FTE Psychologist Fraser Bloomington, MN Hybrid $105,000 - $115,000 annually dependent upon qualifications Fraser Offers: Collaborative and relationship-oriented culture Scheduled performance feedback Career growth opportunities Opportunities for community involvement in Fraser organized events. Collaborative and relationship-oriented culture Fraser Offers Benefits for Full-time Employees (30+ hours per week) Medical, dental and vision insurance Health Savings Account (HSA) and Flexible Spending Account (FSA) Employee Assistance Plan (EAP) Life, AD&D and Voluntary Life Insurance Long-Term Disability, Voluntary Short-Term Disability, Accident Insurance, Critical Illness Insurance and Hospital Indemnity Insurance Pet Insurance 403(b) Retirement Plan with Company Match Work-Life Balance; 5 weeks of paid time off annually (18 days PTO + 9 Paid Holidays) Employee Referral Bonuses Why Join Fraser? Meaningful Impact Help individuals and families lead more connected, independent, and fulfilling lives. Your impact here is real - and lasting. Competitive Pay & Benefits Fraser offers fair pay and comprehensive benefits that support your health, well-being, and future goals. Flexibility & Work-Life Balance With flexible schedules, generous paid time off, and wellness programs, Fraser helps you care for others without sacrificing yourself. Grow Your Career With Us We invest in your development with training, licensure support, leadership pathways, and real opportunities to advance. Culture That Lives Its Values Inclusion isn't just a buzzword - it's how we operate. You'll be seen, heard, and supported to bring your full self to work. Thrive with Stability and Purpose With nearly 90 years of trusted service and continued growth, Fraser is a nonprofit where you can build a lasting, mission-driven career. Fraser is Minnesota's leader in autism, mental health, and disability services - and one of the few Certified Community Behavioral Health Clinics (CCBHCs) in the state. As a nonprofit organization, we provide integrated community behavioral healthcare that improves quality, accessibility, and coordination of care. We lead with compassion, innovate with purpose, and fight for inclusion - every single day. Ready to Build Something Bigger? Join Fraser. Grow with us. Make a difference. Because when you thrive, so does the world around you. Diversity, Inclusion, and Belonging: Fraser values a diverse staff to ensure the best outcomes for our diverse client base. We are committed to anti-racism at Fraser. Our anti-racism committee assesses, develops, and implements numerous initiatives ranging from recruiting and retaining diverse staff to staff training and more. Fraser is an Affirmative Action and Equal Opportunity Employer. This position will be posted at ****************************** until filled. You must apply online here to be formally considered. If you are having trouble applying or have questions, please contact Fraser HR at ****************** or ************. If you have successfully submitted your application, you will get a confirmation email. If you do not receive the confirmation email, please check your junk/spam folders; then contact us as we may not have received your application. Thank you for considering Fraser!

Job Description: Clinical Trial Manager Department: Clinical Affairs Reports To: VP of Clinical Affairs Type: Full-time The Clinical Trial Manager (CTM) will oversee the planning, execution, and delivery of clinical studies to support regulatory submissions and commercialization. The CTM will be responsible for operational leadership of feasibility, pivotal, and post-market trials, vendor and CRO oversight, budget and timeline management, and ensuring compliance with global regulations. This role requires both strategic insight and hands-on execution. Key Responsibilities Lead day-to-day clinical trial operations across all phases (feasibility, pivotal, post-market). Manage study timelines, budgets, and resources to ensure clinical programs are delivered on schedule and within scope. Oversee site selection, qualification, initiation, monitoring, and close-out activities, partnering with CRAs and CROs. Develop and maintain study plans, including monitoring plans, risk management plans, and trial-specific SOPs. Ensure compliance with study protocols, GCP, ICH, FDA, and EU MDR regulations. Act as primary liaison between clinical sites, CROs, vendors, and internal stakeholders. Oversee and review essential study documents, including protocols, informed consent forms, case report forms (CRFs), and clinical study reports (CSRs). Drive enrollment, track progress, and keep stakeholders updated in real time. Maintain data integrity by ensuring timely entry, query resolution, and database lock in collaboration with Data Management. Support regulatory submissions with clinical data and documentation. Prepare for and participate in audits/inspections by regulatory agencies and notified bodies. Mentor and support junior team members, including CRAs and Clinical Trial Assistants. Qualifications Bachelor's degree in life sciences, nursing, or related field (advanced degree preferred). 5+ years of clinical research experience, with 3+ years in clinical trial management. Experience with Class II/III medical devices or pharmaceuticals. Strong knowledge of clinical trial regulations (GCP, ICH, ISO 14155, FDA, EU MDR). Proven track record of managing CROs, vendors, and study budgets. Excellent leadership, organizational, and communication skills. Ability to thrive in a fast-paced, entrepreneurial environment. Ability to work independently, identify and solve problems quickly. Willingness to travel up to 30-40% domestically and internationally. Why Join Opportunity to lead high-impact clinical studies. Competitive salary, bonus, and stock option package. Comprehensive health, dental, and vision coverage. Flexible and collaborative work environment.

The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role ensures the highest quality of statistical and programming support of our hematopoietic stem cell and cellular therapy clinical trials that further the mission, vision and strategic plan of NMDP. The Manager, Biostatistics role will ensure the statistical aspects of clinical activities meet required standards and are robust and valid. This role directly oversees biostatisticians and statistical programmers including hiring, training, leading, overseeing, reviewing work and coaching for growth and development. ACCOUNTABILITIES: Trials oversight: Complete statistical design, planning and analysis duties of individual studies, as needed. Coordinate and oversee statistical deliverables and programming activities of CRO services clinical trials. Collaborate with study statisticians to provide expertise in design of clinical trials. Review and approve protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, datafile specifications, clinical study reports, protocol deviations, clinical publications, and other study documents or communications. Provide guidance on implementation of statistical analysis plans to the study biostatisticians. Develop and maintain statistical and programming policies, guidelines, and procedures (SOPs, training manuals, etc.). Develop and maintain a program to train biostatistician and statistical programmer team members, based on current needs of CRO Services portfolio and strategic direction. Lead standardization efforts, process improvements, and best practices for the team and contribute to cross-functional process improvement efforts. Strategic planning: Define team goals and strategy on an ongoing basis, in collaboration with the Senior Manager, Biostatistics. Provide innovation ideas to Senior Manager, Biostatistics on improving current processes and deliverables including methodology, best practices, and process improvements to maximize biostatistics value and increase efficiency in current resources. Functional leadership: Stay up to date on the latest developments in the statistics and/or programming fields and contribute to scientific advances in the field. Educate the team on new developments and look for ways to implement into current workstreams. Plan, manage, and track team activities, timelines, and resources. Responsible for hiring, development and performance management of assigned team members; ensure team alignment with other department functions. Resolve standard and complex issues raised by the team; escalate unprecedented issues. Coach and develop the team to meet their objectives and growth goals. Facilitate collaboration and interaction between Biostatistics and other teams (Data Management, Safety, Project Management, Monitoring, PRO, Clinical, etc.). Cultivates a culture of inquiry, improvement, and equity. Encourages team members to promote the NMDP values through their daily work. REQUIRED QUALIFICATIONS: Knowledge of: Logistic regression, linear regression, survival analysis and other core statistical methods. Research study design principles and statistical standards for Phase I-III clinical trials. Scientific and therapeutic research concepts, experience in oncology a benefit. Advanced analytical techniques and statistical programming, with high-level proficiency in SAS (and optionally R). Regulatory guidance for clinical trials (e.g. ICH, FDA). Ability to: Think critically. Lead and manage a team effectively. Influence colleagues and stakeholders regarding adoption of new ideas. Demonstrate strong oral and written communication; demonstrate public speaking effectiveness. Manage conflict. Advise senior leaders with confidence on relevant topics. Exhibit strong project management skills with a demonstrated ability to manage teams project milestones in a timely manner. Program with statistical analysis programs, e.g. SAS, R. Education and/or Experience: Master's degree required. Biostatistics concentration preferred, or closely related field where statistical design and analyses comprised the primary course of study and application. 5+ years' experience in performing statistical design/analysis in clinical trials space. 2+ years experience in people leadership or equivalent experience mentoring and coaching others. Preference given to candidates with experience working in the pharmaceutical/medical device industry and working knowledge of CDISC standards.

Details * Schedule: Full-time (40 hours/week) * Salary Range: Starting range $58,406 - $67,183/year (Where an applicant may fall on the salary range will vary based on a variety of factors, including but not limited to experience & education) Benefits * Health Coverage: Medical, Dental & Vision Insurance * Retirement: 401(K) with Company Match, Profit Sharing * Time Off: Generous PTO, Holiday Pay, Floating Holiday * Disability Coverage: Short & Long-Term Disability * Family Support: Paid Leave and Disability * Performance Incentive: Discretionary Bonus Based on Company, Department, and Individual Goals Key Responsibilities General Administration: * Coordinate with PI and Department Manager to ensure that clinical research and related activities are performed in accordance with Federal regulations, GCP, MNGI policies and procedures, and sponsoring agency policies and procedures. * Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, and execution of research plan. Maintain documentation of training. * Assist PI to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with Federal regulations and sponsoring agency policies and procedures. * Coordinate and facilitate monitoring and auditing visits. Notify appropriate organizational and sponsor agency officials of external audits by FDA and sponsors. * Collaborate with PI and institution to respond to any audit findings and implement approved recommendations. Protocol Preparation & Review: * Review and comprehend the protocol. * Attend investigator meetings as required or requested by the sponsoring agency. * Prepare other study materials as requested by the sponsor. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. * Prepare applicable submission forms and submits updated documents. * Create training materials for research PIs, Sub-Is and staff and facilitate documentation of training completion. * Establish and organize study files, including but not limited to the study specific source documentation, the regulatory binders and other materials. Conduct of Research: * Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. * Assist PI in communication of study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Document date of training and signatures of study personnel trained on study specific training log. * Work with the PI and Research Recruitment Specialist to develop and implement recruitment strategies in accordance with IRB requirements and approvals. * Conduct and participate in the informed consent process including interactions with research participants, answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places. Assure that amended consent forms are appropriately implemented and signed. * Collect and review medical records for participants prior to randomization, as needed for safety reporting, and as requested by investigators. * Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion in the study. * Complete and document intake and protocol-specific procedures. * Manage, dispense, and collect investigational product. Assess compliance and provide counseling. * Complete and document investigator orders. * Oversee recruitment activities and coordinate recruitment plan with Research Recruitment Specialist to ensure enrollment goals are met. * Coordinate and schedule participants' tests and procedures. * Collect data as required by the protocol. Assure timely completion of Case Report Forms and resolution of data queries. * Maintain comprehensive knowledge of protocol and study timelines. * Maintain study supplies. * Facilitate and work directly with the PI to manage the administration of investigational products to research patients as stated in the protocol and/or the MNGI policy regarding Investigational Product. * Complete study documentation and maintains study files in accordance with sponsor requirements and MNGI policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. * Retain all study records in accordance with sponsor requirements and MNGI policies and procedures. * Maintain effective and ongoing communication with sponsor, CRO, research participants and PI during the study. * As requested: Prepare, submit, and maintain timely and accurate initial, continuing and final regulatory documents to the IRB, sponsors and state or federal regulatory offices as necessary, including but not limited to: Amendments, Addendums, Investigator's Brochures, Safety Information, Form FDA 1572s and informed consent documents. * Ensure all required documentation and training is completed and filed prior to initial patient recruitment. * As requested by Department Manager: Prepare, maintain, and provide oversight on all research-related regulatory documents. Prepare, submit, and maintain IRB applications for protocol revisions or amendments, changes in subject population, funding, recruitment procedures, site changes, or changes in the informed consent for IRB approved protocols as required by the federal regulations and internal policy. Ensure that all documents are complete and that submission packets meet the IRB's requirements prior to submission. * Responsible for appropriate and timely reporting of protocol deviations and safety events to the sponsor and IRB. * Maintain comprehensive knowledge of reporting requirements of multiple IRBs. * Ensure documents requested by sponsors and IRBs are signed and returned in a timely manner. * Assist Research Regulatory Assistant in preparing regulatory binders and documents for monitoring visits and audits. Meet with sponsor monitors to ensure accuracy of site files. Project Closeout: * Submit closeout documents to the IRB accurately, timely and in accordance with sponsoring agency policies and procedures. * Arrange secure storage of study documents that will be maintained according to MNGI policy or for the contracted length of time, whichever is longer. * Protected Health Information * Adhere to and support all Federal regulations and MNGI policies and procedures instituted to safeguard protected health information (PHI). * Any and all other duties as assigned Essential Functions: In order to perform this job successfully, an individual must be able to perform each essential function satisfactorily and regular attendance is required. The responsibilities listed below are representative of the primary essential functions required; additional duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: * Bachelors degree in science-related field preferred * Two years of experience as a Clinical Research Coordinator with experience managing device or pharmacology trials * One to two years' experience with an electronic health record is preferred Certifications/Licenses: * CCRC (Certified Clinical Research Coordinator) is preferred Qualification Requirements: The qualifications listed below are representative of the knowledge, skills, and/or abilities required to perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge, Skills, and Abilities Required Knowledge * Microsoft Office applications * Medical terminology Required Skills * Compassionate patient care * Active listening * Problem solve, prioritization, and critical thinking * Attention to detail and organization Key Abilities * Multitask * Communicate effectively verbally and in writing * Work independently as well as in a team environment * Type proficiently and accurately Physical Requirements: The physical requirements described here are representative of the physical demands required 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 may be required to walk, sit, stand, reach overhead, and bend to the floor. The employee is regularly required to talk and hear. The employee is required to use dexterity of hands and fingers to operate a computer keyboard, mouse, and other office equipment. Specific vision abilities required by this job include close vision and ability to adjust focus. The employee may be required to lift and transport items up to 15 pounds occasionally. Employees may be required to travel to other company locations due to staffing and training needs. Working Environment: The working environment described here is representative of the setting which an employee may encounter on the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee works in a clinical environment and may be exposed to hazardous chemicals or conditions including exposure to blood or other body fluids. Appropriate Personal Protective Equipment (PPE) and training will be provided. The employee is exposed to a computer monitor daily. The employee may be required to travel by automobile and exposed to changing weather conditions while performing the duties of this position. While performing the duties of this position, the employee must be alert to conditions that may impact the safety of patients, employees and visitors. This job description reflects management's assignment of key responsibilities; it does not prescribe or restrict the tasks that may be assigned. MNGI Digestive Health provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. It is the policy of MNGI Digestive Health to comply with all federal and state laws concerning the employment of persons with disabilities and to act in accordance with regulations and guidance issued by the Equal Employment Opportunity Commission (EEOC). Furthermore, it is the company policy not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment MNGI's Culture of Caring We are caring people, caring for people - working with Compassion, Teamwork, and Integrity * Compassion: being empathetic and considerate of the needs of our patients and caregivers * Teamwork: Being accountable for actions, supporting each other in meeting the needs of our patients, and respecting the voice/opinions of others assuming good intent. * Integrity: Demonstrating honesty, trustworthiness, and transparency whenever you interact with patients or each other.

Our dynamic, clinical-stage, fast-paced medical device startup is developing novel technologies with the potential to significantly change population health. Every team member is a key contributor, directly impacting the company's progress towards commercialization. They offer a challenging yet rewarding environment where individuals can thrive and see the direct impact of their work. Due to an internal promotion, they are seeking a Clinical Trial Payments/Clinical Trial Coordinator.This role is a backfill to support an existing team member's growth into a Clinical Research Associate role. The specialist will be crucial in managing clinical trial payments and operating within their Clinical Trial Management System for new in-house projects. This position offers a significant growth opportunity for the right individual. Your role with the company: Clinical Trial Payments (approx. 50% of role): Manage and oversee clinical trial payments, which will be a heavy focus for at least the next year. Conduct administrative tasks and auditing of payments processed by their third-party vendor, Ledger Run. Navigate complex and often inconsistent clinical trial contracts, ensuring accurate and timely payments. Address various invoiceable items and ensure consistency across sites. Requires a strong understanding of clinical trial nuances; general bookkeeping experience is insufficient. CTMS Management (approx. 50% of role): Operate and manage activities within the Clinical Trial Management System (CTMS), specifically Simple Trials. Perform filing, binder creation, and other essential TMF/CTMS management duties for two new in-house projects (no CRO involvement for U.S. operations). Experience with other CTMS systems is valuable and should allow for quick adaptation to Simple Trials. General Clinical Trial Assistance: Take meeting minutes. Provide presentation assistance. Contribute to other ad hoc tasks as needed within a small, dynamic team. Desired Profile: Proven experience in clinical trial payments is essential. Familiarity and comfort operating within a Clinical Trial Management System (CTMS). Ability to work effectively in a fast-paced environment. Openness to feedback and a straightforward communication style. Strong organizational skills and attention to detail. Experience in a healthcare setting is a plus. Ability to manage multiple tasks and priorities.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD. The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines. Job Summary Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions * Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. * Recruiting patients for clinical trials, conducts phone interviews. * Verifies the accuracy of study forms and updates them per protocol. * Prepares data for analysis and data entry. * Documents patient visits and procedures. * Assists with regulatory binders and QA/QC Procedures. * Assists with interviewing study subjects. * Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Onsite Work Location 1 Maguire Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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.

Park Nicollet is looking to hire an Oncology Research Nurse to join our Research and Education team! Come join us as a Partner for Good and help us make an impact on the care and experience that our patients and their families receive every day. Position Summary: Independently oversees and provides patient care management and education, or conducts research using sound nursing judgment, critical thinking, and clinical knowledge and skills. Serves as a mentor/resource to other research and education staff Provides clinical consultative, educational and research support. Collaborates with primary care and specialty departments within PNHS Interacts with the community and external customers, and disseminates knowledge and expertise to other health professionals including oral presentations and written manuscripts. The Metro-Minnesota Community Oncology Research Consortium (MMCORC) is a nonprofit research program sponsored by the National Cancer Institute (NCI) and participating hospitals and clinics. We are a consortium consisting of 25 community hospitals and oncology clinics with over 160 physician members in the Minneapolis/St. Paul metro-area and surrounding communities, extending to the western Wisconsin area. Our programs mission is to bring the advantages of cancer research to the community. MMCORC provides the opportunity for patients and physicians to have access to National Cancer Institute (NCI) and pharmaceutical sponsored clinical trials for all types of adult cancer. This program provides people in our community access to: The newest therapies available for cancer treatment Management of treatment side effects and disease symptoms Studies directed at cancer prevention Molecular-based precision medicine research Cancer care delivery research This position will be based primarily at Methodist Hospital and an affiliated oncology clinic in St. Louis Park, MN with the need to travel to other local sites. Will consider a lower FTE for the right candidate. Please visit our website for more information about our program: ************** This Oncology Research Nurse position will work collaboratively with physicians in identifying and managing patients on NCI and pharmaceutical sponsored clinical trials. This position involves direct patient care and involves a strong patient advocacy role. Additional responsibilities include: Screens potential patients for protocol eligibility. Presents trial concepts and details to patients, participates in informed consent process, and enrolls patients onto clinical trials. Coordinates patient care in compliance with protocol requirements. Distributes investigational drug and provides patient teaching regarding administration. Maintains accurate investigational drug accountability records. In collaborations with the physician, assesses patients for changes in conditions, adverse events, concomitant medications use, protocol compliance, response to study drug, and thoroughly documents all findings. Reports adverse drug reactions and protocol deviations to study sponsor, NCI and FDA according to prescribed reporting system. Responsible for accurate and timely data collection, documentation, data entry, and reporting. Participates in monitoring and auditing activities and study visits. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. Special Knowledge/Skills: Oncology nursing experience preferred. Strong critical thinking, assessment, and problem-solving skills. Understands and applies teaching/learning principles. Works independently, as well as collaboratively, displaying effective communication skills. Supportive of team members. Works in concert with team members and interdisciplinary staff. Strong prioritization, multi-tasking skills, and ability to handle large workload. Have a strong drive for results with patient centered focus. Come join our team of researchers as we bring the advantages of cancer research to the community. Work Schedule: M-F 8:00am - 4:30pm Required Qualifications: Education, Experience or Equivalent Combination: BA, BS, AD, in Nursing from a college or university One to three years of experience as an RN Licensure/ Registration/ Certification: Current RN licensure in the state of Minnesota Knowledge, Skills, and Abilities: Demonstrates knowledge of age-related growth and development principles necessary to provide appropriate service and assure safety of patients. This position requires familiarity and compliance with matters of law, regulations and internal policies affecting the employment relationship, (including but not limited to FMLA, ADA, discrimination, and harassment laws). Proven proficiency in the operation of the following: Personal Computer, Telephone, Fax Machine, Photocopier, Printer, and electronic medical record. Preferred Qualifications: Education, Experience or Equivalent Combination: Master's Degree Licensure/ Registration/ Certification: Certification Diabetes Care and Education Specialist (CDCES) preferred for IDC Patient Services position. Certified Clinical Research Coordinator (CCRC) or other applicable certification preferred for IDC Research position. Knowledge, Skills, and Abilities: Strong critical thinking, assessment, and problem-solving skills Understands and applies teaching/learning principles. Works independently, as well as collaboratively, displaying effective communication skills. Supportive of team members Works in concert with team members and interdisciplinary staff Strong prioritization, multi-tasking skills and ability to handle large workload. Benefits: Park Nicollet offers a competitive benefits package (for eligible positions) that includes medical insurance, dental insurance, a retirement program, time away from work, insurance options, tuition reimbursement, an employee assistance program, onsite clinic and much more!

The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff "for fit" makes significant contributions to Howard University's overall mission. At Howard University, we prioritize well-being and professional growth. Here is what we offer: * Health & Wellness: Comprehensive medical, dental, and vision insurance, plus mental health support * Work-Life Balance: PTO, paid holidays, flexible work arrangements * Financial Wellness: Competitive salary, 403(b) with company match * Professional Development: Ongoing training, tuition reimbursement, and career advancement paths * Additional Perks: Wellness programs, commuter benefits, and a vibrant company culture Join Howard University and thrive with us! *************************************** JOB PURPOSE: To coordinate study participants in the Clinical Trials Unit. Execute tasks as required by the study protocols. SUPERVISORY AUTHORITY: Involves no responsibility or authority for the direction of others. NATURE AND SCOPE: Interacts with physicians, immediate staff members, research participants, and the general public. PRINCIPAL ACCOUNTABILITIES: * Maintain familiarity with the protocol. Evaluate study candidates for eligibility into the study. * Meet with the patient's caretaker to review the details of study enrollment. * Assure that informed consent has been obtained from the patient's legal guardian and consent from the patient when applicable prior to the initiation of research-related activities. * Schedule tests and appointments for patients within appropriate timeframes. * Send the prescriptions for study medication to the research pharmacist, including the height, weight or body surface area. * Identifying abnormal laboratory results and obtain repeat evaluations are required by the protocol. * Complete case report forms accurately and thoroughly and enter data electronically. * Maintain source documentation in shadow files for each study participant. * Respond to date inquiries in a timely manner. * Complete Serious Adverse Even Reports within the proper timeframes. * Report to the Project Director and the Principal Investigator regarding assignments and duties. * Perform other duties as instructed by the Principal Investigator and Project Director. CORE COMPETENCIES: * Knowledge of clinical trials protocols. * Knowledge of management regulations of Howard University. * Knowledge of the educational and research goals of grant. * Knowledge of federal and Howard University grant policies, administration and regulation. * Excellent skill in the operation of desktop computer and software applications to include e-mail and * calendar functionality, word processing, spreadsheet applications and presentation software. * Competence in both oral and written English to communicate in a clear and concise manner. * Ability to establish and maintain effective and harmonious work relations with faculty, staff, students and customers. * MINIMUM REQUIREMENTS: Minimum of a Bachelor of Science degree. Course study concentration in a health-related field is desirable. Compliance Salary Range Disclosure $50,000-$60,000

This role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as study coordinator to execute trials conducted within physician practices, including but not limited to: Visit preparation activities Visit follow-up activities Supply and inventory management Third party vendor coordination Conduct patient recruitment and enrollment of eligible patients Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. Independently administer the informed consent process with care and quality Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Attend study start-up and planning meetings, including PSVs and SIVs 8. Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Assist in Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience 3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 3+ years of experience independently coordinating studies, from study startup to close out 3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience 2+ years expert knowledge of FDA regulations and ICH/GCP guidelines We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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 ********************************** ************

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: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * 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 talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual 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. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

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://*******************/