Clinical research coordinator jobs in Saint Paul, MN - 81 jobs
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Clinical Research Coordinator
Clinical Research Specialist
Clinical Research Associate
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Clinical Researcher
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Study Coordinator
Clinical Research Manager
Clinical Trial Documentation Coordinator
Cypress HCM 3.8
Clinical research coordinator job in Maple Grove, MN
The Clinical Trial Documentation Coordinator plays a vital role within the Clinical Operations team, providing seasoned administrative and logistical support across a variety of clinical trial activities. This role is responsible for ensuring studies are well-organized, audit-ready, and progressing smoothly by flexibly managing documentation, image and data tracking, payments, device logistics, and meeting coordination. As a core and consistent member of the team, the ClinicalCoordinator is regarded as a peer among fellow coordinators and a reliable contributor to study success.
Responsibilities:
Clinical Documentation & Site Support
Manage essential clinical documentation, including IRB approvals, informed consent forms, agreements, and regulatory files.
Track and update CVs and credentials for study site personnel.
Serve as a primary contact for clinical sites regarding documentation needs and visit scheduling.
Maintain organized, audit-ready study files within electronic systems.
Image & Data Management
Coordinate the collection, processing, and tracking of clinical images and related data from sites and core labs.
Troubleshoot and resolve data submission issues with sites and vendors to ensure completeness and timeliness.
Ensure image data quality and compliance by maintaining accurate records in the EDC system.
Payments & Financial Tracking
Process payments to study sites, vendors, core labs, and data management groups.
Maintain and update payment tracking databases; provide accrual information to the Finance team.
Communicate regularly with vendors and sites to support timely and accurate financial transactions.
Device & Logistics Coordination
Manage logistics for study device shipments, returns, and related documentation.
Track device inventory, usage, and return status.
Collaborate with Operations to facilitate purchase orders and coordinate shipping logistics.
Meeting & Training Support
Assist with planning and coordinating investigator meetings, site coordinator trainings, and study committee meetings (in-person and virtual).
Support travel arrangements and meeting logistics as needed.
Prepare training materials, track participant attendance, and monitor related expenses.
General Team Support
Assemble and maintain study materials, binders, and equipment supplies.
Provide backup support to fellow ClinicalCoordinators during periods of high workload.
Participate in continuous improvement efforts and team-wide initiatives.
Qualifications:
Associate or Bachelor's degree required; degree in life sciences, healthcare, or a related field preferred.
3-5 years of experience in clinicalresearch, clinical trials, or a regulated healthcare setting.
Strong understanding of clinical documentation requirements and trial operations.
Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook); experience with EDC systems or clinical databases is highly preferred.
Exceptional organizational skills with the ability to handle multiple priorities in a dynamic environment.
High attention to detail, accuracy, and follow-through.
Excellent communication skills and the ability to foster productive relationships with internal teams, clinical sites, and vendors.
Demonstrated dedication to a coordinator-level role and a commitment to team stability and performance.
Salary of $60,000 to $80,000 + 5 to 7 % bonus
$60k-80k yearly 2d ago
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Clinical Research Coordinator - 248147
Medix 4.5
Clinical research coordinator job in Minneapolis, MN
Job Title: ClinicalResearchCoordinator - 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 ClinicalResearchCoordinator 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 clinicalresearch 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 clinicalresearch.
Strong interpersonal skills and the ability to collaborate effectively with diverse teams.
Reliable follow-through and commitment to timely communication.
$41k-57k yearly est. 1d ago
Sr Clinical Research Specialist
Collabera 4.5
Clinical research coordinator job in Minneapolis, MN
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. ClinicalResearch Specialist (Sr. CRS) will support the execution of clinicalresearch 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 clinicalresearch (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
************
$72k-101k yearly est. 14h ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Clinical research coordinator job in Minneapolis, MN
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 clinicalresearch processes and regulations.
• Certifications such as Society of ClinicalResearch Associates (SoCRA) or Association of ClinicalResearch Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House ClinicalResearch Associates; up to 80% travel for Field ClinicalResearch 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.
$54.4k-80.1k yearly Auto-Apply 57d ago
Clinical Research Specialist III
Integrated Resources 4.5
Clinical research coordinator job in Mounds View, MN
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), ClinicalResearch, Rehabilitation Therapy and Nursing.
Job Description
Job Title: ClinicalResearch Specialist III
Location: Mounds View, MN
Duration: 4+ Months (Possibility of extension)
Job Roles & Responsibilities
Senior level ClinicalResearch Specialist with proficiency in BIMO audit preparation needed.
Team is preparing for a PMA (pre market application) submission.
Main duties of project are as follows
:
·
Extensive review of Trial Master File and Site Files to ensure files are complete, accurate and compliant with ISO14155, applicable FDA Code of Federal Regulations, project plans and MDT internal SOPs.
·
Critical review of target records, to identify any audit risks; recommend or take action to mitigate risks
·
Document file review, all findings and actions as a deliverable to the Clinical Trial Manager
Experience required
: 5 plus years
E
ducational:
Bachelor's degree required.
Top 3 skills needed
·
Experience with BIMO Audits and Audit prep
·
Audit background good organizational skills.
·
Strong working knowledge of documentation required for FDA and ISO 41455 audits.
Full time hours - 40/week.
Additional Information
We do have referral bonus of $500 per candidate, 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
Email id - seema @irionline.com| www.irionline.com
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)
$65k-95k yearly est. 14h ago
Senior Clinical Research Specialist
Gateway Recruiting
Clinical research coordinator job in Minneapolis, MN
Job Description
About the role: The Senior ClinicalResearch Specialist will join the Urology Biostatistics and Real World Evidence team. This role supports key commercialized products by developing and executing clinicalresearch activities from real-world data sources and driving long-term evidence strategies. This role creates and maintains all documentation pertaining to clinicalresearch 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 clinicalresearch 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
$53k-82k yearly est. 6d ago
Clinical Research Scholar, Center for Coronary Artery Disease
Minneapolis Heart Institute Foundation 3.5
Clinical research coordinator job in Minneapolis, MN
Job DescriptionAn established cardiology research team (Principal investigator - PI: Emmanouil Brilakis, MD, PhD) invites applications for a full-time research scholarfor a period of at least two years. Our research team is based at the Minneapolis Heart Institute Foundation (MHIF) in Minneapolis, Minnesota, USA and works in collaboration with the Minneapolis Heart Institute at Abbott Northwestern Hospital (MHI), part of the Allina Health System. The team is conducting several clinical studies, including the PROGRESS-CTO registry, PROGRESS Bifurcation Registry, the PROGRESS Complications Registry and the REBIRTH Trial. We are seeking a highly motivated researcher who is interested in studying coronary artery disease and contributing to progress in the field.
The Research Scholar will be responsible for conducting clinicalresearch studies and using good clinical practice guidelines under the supervision of the PI. The Research Scholar will develop significant expertise in designing and executing clinical studies, both prospective and retrospective, single-center and multi-center. Moreover, they will acquire significant experience in medical writing and the publication process. The Research Scholar will also gain experience in preparing and submitting abstracts and challenging cases to scientific congresses, and in presenting their work in oral and/ or poster formats. Previous and current Research Scholars in the program have been very successful in publishing and securing clinical residency/fellowship training positions. This research position has no patient care responsibilities.
Duration
: We will assist the chosen scholar in the acquisition of a research visa. We are looking for a minimum commitment of 2 years full-time to optimize this training, education, research and publication experience.
Primary Responsibilities:
1. Initial research relates to chronic total occlusions/ coronary bifurcations/ cardiac catheterization and PCI complications, comparison of treatment/procedural strategies and outcomes. The scholars will evaluate the pathogenesis of the various components of complex coronary artery disease, as well as innovative treatments. The incumbent will also investigate and contribute actively to scientific work in the areas of complex coronary artery disease such as saphenous vein graft disease, complex high-risk indicated procedures/ percutaneous coronary intervention procedures and comparison of arterial access for percutaneous procedures.
2. Participate in the development and execution of the ongoing investigator-initiated trials at the Minneapolis Heart Institute Foundation. The scholars will be involved in development of creation of study databases, collaboration with research staff at the coordinating center as well as sites in collecting and analyzing study data, as well as recruitment of study participants.
3. Support “Get with the guidelines”: Creating systems and process so all coronary artery disease patients are treated according to best practice guidelines.
Investigate guideline adherence and discover barriers that limit coronary artery disease patients from receiving standard of care.
Design, develop, and implement novel patient care pathways leading to optimal guideline-based care.
4. Help expand the delivery of high-quality, state-of-the-art care for patients with coronary artery disease.
Greatly improve coronary artery disease treatment outcomes by expanding treatment indications.
Discover disease related mechanisms and early intervention methods to prevent advancing coronary artery disease.
Drive early adoption of innovative therapies
5. Innovate novel education methods to disseminate best in class clinical care models
Create a model where all physician/providers deliver optimal coronary artery disease care.
Educate consumers and patients on seeking the state-of-the-art care in the prevention, screening, diagnosis, and treatment of coronary artery disease.
Qualifications
:
Medical degree with track record of excellence required
Interest in coronary artery disease, exposure to cardiology/interventional cardiology
specialty training in general cardiology and/or interventional cardiology is preferred
Knowledge of basic statistical methods
Skilled and versatile with computer technology including the Microsoft suite including Excel, comfort with databases and preferably some website development skills
Flexible and adaptable to work on a variety of studies and tasks
Proficiency in English (verbal and written)
Salary
: The Research fellow will receive a full-time salary at the prevailing wage, $56,368 and employee benefits including medical, dental, life, short and long term disability, HSA with employer contributions, PTO, parental leave, tuition reimbursement, paid volunteer time, and 10 paid holidays.
Include your CV and USMLE scores if completed and two letters of reference.
For positions starting Spring of 2026, application timelines are as follows:
Deadline for application submission: October 1, 2025
Interviews scheduled through October 31, 2025
Selected candidates will be notified on or before November 29, 2025
Applications will be accepted on a rolling basis and maybe considered for the following year or the year after.
$51k-68k yearly est. 21d ago
Clinical Research Scholar, Center for Coronary Artery Disease
Mlnneapolis Heart Institute Foundation
Clinical research coordinator job in Minneapolis, MN
An established cardiology research team (Principal investigator - PI: Emmanouil Brilakis, MD, PhD) invites applications for a full-time research scholarfor a period of at least two years. Our research team is based at the Minneapolis Heart Institute Foundation (MHIF) in Minneapolis, Minnesota, USA and works in collaboration with the Minneapolis Heart Institute at Abbott Northwestern Hospital (MHI), part of the Allina Health System. The team is conducting several clinical studies, including the PROGRESS-CTO registry, PROGRESS Bifurcation Registry, the PROGRESS Complications Registry and the REBIRTH Trial. We are seeking a highly motivated researcher who is interested in studying coronary artery disease and contributing to progress in the field.
The Research Scholar will be responsible for conducting clinicalresearch studies and using good clinical practice guidelines under the supervision of the PI. The Research Scholar will develop significant expertise in designing and executing clinical studies, both prospective and retrospective, single-center and multi-center. Moreover, they will acquire significant experience in medical writing and the publication process. The Research Scholar will also gain experience in preparing and submitting abstracts and challenging cases to scientific congresses, and in presenting their work in oral and/ or poster formats. Previous and current Research Scholars in the program have been very successful in publishing and securing clinical residency/fellowship training positions. This research position has no patient care responsibilities.
Duration
: We will assist the chosen scholar in the acquisition of a research visa. We are looking for a minimum commitment of 2 years full-time to optimize this training, education, research and publication experience.
Primary Responsibilities:
1. Initial research relates to chronic total occlusions/ coronary bifurcations/ cardiac catheterization and PCI complications, comparison of treatment/procedural strategies and outcomes. The scholars will evaluate the pathogenesis of the various components of complex coronary artery disease, as well as innovative treatments. The incumbent will also investigate and contribute actively to scientific work in the areas of complex coronary artery disease such as saphenous vein graft disease, complex high-risk indicated procedures/ percutaneous coronary intervention procedures and comparison of arterial access for percutaneous procedures.
2. Participate in the development and execution of the ongoing investigator-initiated trials at the Minneapolis Heart Institute Foundation. The scholars will be involved in development of creation of study databases, collaboration with research staff at the coordinating center as well as sites in collecting and analyzing study data, as well as recruitment of study participants.
3. Support “Get with the guidelines”: Creating systems and process so all coronary artery disease patients are treated according to best practice guidelines.
Investigate guideline adherence and discover barriers that limit coronary artery disease patients from receiving standard of care.
Design, develop, and implement novel patient care pathways leading to optimal guideline-based care.
4. Help expand the delivery of high-quality, state-of-the-art care for patients with coronary artery disease.
Greatly improve coronary artery disease treatment outcomes by expanding treatment indications.
Discover disease related mechanisms and early intervention methods to prevent advancing coronary artery disease.
Drive early adoption of innovative therapies
5. Innovate novel education methods to disseminate best in class clinical care models
Create a model where all physician/providers deliver optimal coronary artery disease care.
Educate consumers and patients on seeking the state-of-the-art care in the prevention, screening, diagnosis, and treatment of coronary artery disease.
Qualifications
:
Medical degree with track record of excellence required
Interest in coronary artery disease, exposure to cardiology/interventional cardiology
specialty training in general cardiology and/or interventional cardiology is preferred
Knowledge of basic statistical methods
Skilled and versatile with computer technology including the Microsoft suite including Excel, comfort with databases and preferably some website development skills
Flexible and adaptable to work on a variety of studies and tasks
Proficiency in English (verbal and written)
Salary
: The Research fellow will receive a full-time salary at the prevailing wage, $56,368 and employee benefits including medical, dental, life, short and long term disability, HSA with employer contributions, PTO, parental leave, tuition reimbursement, paid volunteer time, and 10 paid holidays.
Include your CV and USMLE scores if completed and two letters of reference.
For positions starting Spring of 2026, application timelines are as follows:
Deadline for application submission: October 1, 2025
Interviews scheduled through October 31, 2025
Selected candidates will be notified on or before November 29, 2025
Applications will be accepted on a rolling basis and maybe considered for the following year or the year after.
$48k-69k yearly est. Auto-Apply 60d+ ago
Research Coordinator - Clinical
Twin Cities Spine 3.8
Clinical research coordinator job in Minneapolis, MN
*Candidates must be a Minnesota resident.
Job Status: Full-time (Monday - Friday)
We are seeking a motivated and talented ClinicalResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinators, 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 clinicalresearch
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.
$41k-58k yearly est. Auto-Apply 6d ago
Clinical Research Coordinator
Invitrogen Holdings
Clinical research coordinator job in Richfield, MN
Join us as a ClinicalResearchCoordinator - 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 clinicalresearch 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: *****************************************************
$40k-58k yearly est. Auto-Apply 4d ago
Clinical Research Coordinator I
Center for Veterans Research and Education
Clinical research coordinator job in Minneapolis, MN
Job Description
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 ClinicalResearchCoordinator I
Position Description:
The ClinicalResearchCoordinator is responsible for the day-to-day operations of multiple clinicalresearch studies. This position will actively enroll patients at the Minneapolis VA Medical Center.
Responsibilities: Major duties and responsibilities may include, but are not limited to the following:
Maintain close communication with local and network study leadership and staff.
Manage the study start-up process, including finalization of Informed Consent Forms
and preparation of study start-up materials.
Collaborate with the central Institutional Review Board overseeing VA sites, and the
local Research and Development Committee (RDC), to ensure that regulatory
requirements at the local site are identified, communicated, and observed.
Oversee enrollment and study activities with the Site Investigator.
Recruit participants, collect data in accordance with established study procedures,
follow up with participants in a timely manner.
Dispense and track investigational study drug per protocol and in keeping with safe
medication handling practices.
Conduct phlebotomy and urine sample collection per study protocol.
Coordinate home visits between contract Home Health Service and study participants.
Monitor subjects' progress, including documentation and reporting of adverse events.
Ensure staff and subject compliance with protocol guidelines and requirements of
regulatory agencies.
Implement protocols to ensure data is collected in a scientifically valid manner.
Serve as primary liaison with Site Investigator, staff, internal/external resources and
sponsor regarding patient care issues and progress of the study.
Maintain local budgets for the study; regularly report progress on all aspects of the
project to the Site Investigator.
Prepare documentation to support billing for this study's sub-award, in cooperation
with CVRE staff.
Track expected and annual payments from the sponsor, in cooperation with CVRE staff.
Perform administrative functions including meetings, setting up and participating in
conference calls, maintaining written correspondence, and transcribing memoranda.
Ensure that study activities are completed in an ethical, culturally responsive,
scientifically rigorous, and timely manner in accordance with principles of Good Clinical
Practice and Federal Policies for the Protection of Human Subjects.
Responsible for alerting the Site Investigator of data collection/protocol breeches, inconsistencies, or other problems that may arise within the study, as well as suggesting methods of correction.
Maintain data and study files in accordance with study protocols
Other duties as assigned
Applicants must include a cover letter
Minimum Qualifications:
Education: Bachelor's Degree required (Master's preferred)
Experience: 1-3 years of Research Assistant experience, or equivalent education/experience
0-2 years of Coordinator experience required for CRC I
Preferred working knowledge of the study
Licensure/Registration/Certification: None
Knowledge, Skills, and Abilities:
Demonstrated ability to work effectively both independently and as part of a team.
Ability to evaluate the quality of data collected and progress toward overall program objectives
Experience in coordinating multiple tasks and project elements with differing timelines and completion deadlines.
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' protections, and federal regulations relating to clinicalresearch
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 life up to 25 lbs. Reasonable accommodation may be considered in determining an applicant's ability to perform the duties/functions of the position.
$40k-58k yearly est. 5d ago
Clinical Research Coordinator - Contract
Talencio
Clinical research coordinator job in Minneapolis, MN
The ClinicalResearchCoordinator (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 clinicalresearch, 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 clinicalresearch.
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 ResearchCoordinator meetings
Position based in Maple Grove, MN
$40k-58k yearly est. 3d ago
Clinical Research Spec - Exempt
Lancesoft 4.5
Clinical research coordinator job in Mounds View, MN
Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinicalresearch. 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.
$57k-77k yearly est. 47d ago
Clinical Research Coordinator I
Brigham and Women's Hospital 4.6
Clinical research coordinator job in Lexington, MN
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 ResearchCoordinator I to implement a portfolio of clinicalresearch trials and projects related to ASD.
The ClinicalResearchCoordinator I will work under the supervision of the Senior ClinicalResearch Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinicalresearch 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 clinicalresearch 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 clinicalresearch 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:
1200 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.
$19.8-28.4 hourly Auto-Apply 6d ago
Home Health Clinical Coordinator
Accurate Home Care 4.1
Clinical research coordinator job in Otsego, MN
Full Time Home Health ClinicalCoordinator
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 ClinicalCoordinator.
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 ClinicalCoordinator 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
$20-25 hourly 9d ago
Clinical Coordinator
Saint Therese 3.8
Clinical research coordinator job in New Hope, MN
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://*******************/
$38k-50k yearly est. 14h ago
Sr Clinical Research Specialist
Collabera 4.5
Clinical research coordinator job in Minneapolis, MN
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. ClinicalResearch Specialist (Sr. CRS) will support the execution of clinicalresearch 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 clinicalresearch (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
**********************************
************
$72k-101k yearly est. Easy Apply 60d+ ago
Associate Study Coordinator
Namsa 4.2
Clinical research coordinator job in Minneapolis, MN
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.
$17.8-26 hourly Auto-Apply 18d ago
Research Coordinator - Clinical
Twin Cities Spine Center 3.8
Clinical research coordinator job in Minneapolis, MN
* Candidates must be a Minnesota resident. Job Status: Full-time (Monday - Friday) We are seeking a motivated and talented ClinicalResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinator 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 ResearchCoordinators, 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 clinicalresearch
* 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.
$41k-58k yearly est. 6d ago
Clinical Research Project Manager
Brigham and Women's Hospital 4.6
Clinical research coordinator job in Cambridge, MN
Site: The Spaulding Rehabilitation 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.
Job Summary
Summary
Responsible for executing on a daily basis, the procedural, managerial and policy decisions made for the studies. Participates in all decisions made for the studies and identifies modifications of existing policies and procedures. Responsible for budget oversight and participates in grant writing and proposals.
Does this position require Patient Care? No
Essential Functions
* Responsible for the coordination and implementation of research design process and study protocols at one or multiple sites.
* On a daily basis, executes the procedural, managerial, and policy decisions made for the studies.
* Participates in all decisions made for the studies and the formulation of policies and procedures.
* Identifies modifications needed and works to implement solutions.
* Responsible for the development and oversight of project budgets.
* Participates in grant writing and proposals.
* Serves as the primary contact for outside vendors utilized to ensure efficient operation of the studies.
* Responsible for the oversight of all supplies, equipment and files.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
No
Experience
Research Related Experience 3-5 years required
Knowledge, Skills and Abilities
* Strong organizational skills and Communication skills.
* Demonstrated analytical skills.
* Effective problem solving skills.
* Strong computer skills.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
300 First Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$62,004.80 - $90,750.40/Annual
Grade
7
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:
1400 The Spaulding Rehabilitation 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.
$62k-90.8k yearly Auto-Apply 2d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Saint Paul, MN?
The average clinical research coordinator in Saint Paul, MN earns between $33,000 and $70,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Saint Paul, MN
$48,000
What are the biggest employers of Clinical Research Coordinators in Saint Paul, MN?
The biggest employers of Clinical Research Coordinators in Saint Paul, MN are: