Clinical Coordinator
4 weeks ago
Description:
Working under direct supervision, provide clinical study administrative support to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards and SJM Standard Operating Procedures. Performs routine assignments in this entry level position. Focus is on supporting administrative functions related to clinical
study(s) which may include maintaining Clinical Trial Master File, site regulatory documents and device shipping and tracking. Assist with the coordination of safety board meetings which may include preparation of documents, coordination of meeting venue and travel. Provide assistance with core labs which includes tracking receipt of test results and invoices.
Responsibilities:
1. File Management
- Set-up and maintain Clinical Trial Master File.
- Set-up and maintain site study files.
- Maintain source document files.
2. Provide support to Clinical Project Teams
- Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
- Maintain records of investigational devices for all assigned regulated studies.
- Facilitate the order and release of clinical IDE device inventory.
- Process invoices as needed and review payment report if applicable.
- Run IRB renewal status report and notify sites of pending IRB renewals.
- Create site regulatory/subject binder(s) and ship to sites.
- Assist with collection of site activation documents.
- Organize and track shipment of study related documents.
- Support and track shipment of project related equipment/data between centers, sponsor and core labs.
- Assist with core labs such as tracking receipt of test results and invoices.
- Attend project related meetings; write meeting minutes as applicable.
- Assist with Investigator/Committee, etc. meetings such as travel arrangements, hotel, conference rooms, etc.
- Collect, file and de-identify adverse event source documents.
- Receive and file study related documents in the appropriate location.
- 3. Able to handle multiple assignments in a timely manner while meeting assigned deadlines.
- 4. Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
Other Duties:
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Equipment:
- Uses standard office equipment, including (but not limited to) personal computer, telephone,
- FAX, and copier.
Working Conditions:
- Normally works in a cubicle situated in open landscape office environment. Air conditioned.
- Well lighted. Moderate noise level.
Physical Demands:
- Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination.
Qualifications:
Required:
- High school diploma/secondary school degree.
- Proficient in operating a personal computer and in using various PC-based software packages including Word, Excel, or similar word processing/spreadsheet software.
- Must have strong organizational skills and attentiveness to detail.
- Must also have verbal and written communication, interpersonal, organizational and basic math skills.
- The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation.
- Must be able to use discretion and handle sensitive/confidential information.
- The ability to work independently when necessary.
- The ability to exchange straightforward information, ask questions, and check for understanding.
- Must be able to maintain regular and predictable attendance.
Desired:
- A Bachelor’s degree from an accredited university or college.
- A general familiarity with cardiac, vascular, and/or neuromodulation technologies, and clinical research processes. Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
- Previous Customer Service experience including interacting with customers, answering customer questions and providing information.
-
Patient Service Coordinator
1 day ago
Maple Grove, United States Children's Hospitals and Clinics of Minnesota Full timeAbout Children’s Minnesota Children’s Minnesota is one of the largest pediatric health systems in the United States and the only health system in Minnesota to provide care exclusively to children, from before birth through young adulthood. An independent and not-for-profit system since 1924, Children’s Minnesota is one system serving kids throughout...
-
Sport Coordinator Soccer
3 weeks ago
Maple Grove, United States i9 Sports - Northwest Metro Minneapolis Full timeJob DescriptionJob DescriptionBenefits/PerksA team-based atmosphere with a focus on Fun!Opportunity to build coaching skills and be a role model for athletesOnline training opportunitiesCompany OverviewFounded in Tampa, Florida, i9 Sports is the nations first and largest youth sports league franchise business in the United States with over 1 million...
-
Sport Coordinator Baseball
2 weeks ago
Maple Grove, United States i9 Sports - Northwest Metro Minneapolis Full timeBenefits/Perks A team-based atmosphere with a focus on Fun! Opportunity to build coaching skills and be a role model for athletes Online training opportunities Company OverviewFounded in Tampa, Florida, i9 Sports® is the nation’s first and largest youth sports league franchise business in the United States with over 1 million registrations in more than...
-
Clinical Research Coordinator
4 weeks ago
Garden Grove, United States National Institute of Research, Inc. Full timeJob DescriptionJob DescriptionNational Institute of Clinical Research, a research organization serving the pharmaceutical and biotech industries, is searching for a Clinical Research Coordinator with 2 or more years of experience in Psychiatry trials.Duties for this position will include managing the study from placement to completion of the final study...
-
Clinical Research Coordinator
2 weeks ago
Willow Grove, United States Insight Global Full timeDay-to-Day:A large healthcare company is looking to hire a Clinical Research Coordinator in Abington, PA. This person must have a car as they are going back and forth between the cancer center and hospital (few miles). This person will run portions of clinical trials, process research samples, obtain signatures for informed consent, central lab management,...
-
Clinical Staff Development Coordinator
2 weeks ago
Garden Grove, United States Genesis Healthcare Services Full timeClinical Staff Development Coordinator - LPN #496201 Alta Gardens Care Center - Genesis HealthCare Position Type Full Time 496201 Requisition Number 496201 Alta Gardens Care Center - Genesis HealthCare State California Job Description Benefits *Nursing Student Loan Debt Repayment and Tuition Assistance *Tuition, Travel, and Wireless Service...
-
Rehab Therapy Tech
4 weeks ago
Maple Grove, Minnesota, United States i-Health Full timeThe Therapy Technician will support Therapists and Therapist Assistants in providing aspects of therapeutic healthcare services to patients as well as assist with clinical responsibilities.Monday-Friday 4hr shift between 8am-4pm at Maple Grove 4 days/week and Robbinsdale 1 day/week.Twin Cities Orthopedics is an operating division of Infinite Health...
-
EMT/Medical Assistant/LPN
2 days ago
Maple Grove, United States University of Minnesota Physicians Full timeWhy M Physicians? Otolaryngology (also known as ear, nose and throat, or ENT) is the branch of medicine that specializes in the diagnosis and treatment of a broad range of ear, nose, throat, head and neck problems. We work closely with providers from several different specialties, including audiology, neurology, neurosurgery, speech language pathology,...
-
Downers Grove, IL 60516, USA, United States Midwestern University Full timeThe Clinical Skills Coordinator provides administrative support and coordination of activities in the Clinical Skills and Simulation Center. This position reports to the Assistant Director, Clinical Skills and Simulation Center. Essential Duties and Clinical, Skills, Simulation, Coordinator, Clinic, Customer Service, Healthcare
-
Oncology Clinical Research Coordinator
2 weeks ago
Elk Grove Village, United States Ascension Health Full timeDetails * Department: Research * Schedule: Full Time, Day Shifts * Hospital: Ascension Alexian Brothers * Location: Elk Grove Village, Illinois Benefits Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental...
-
Neurosciences Clinical Research Coordinator
2 weeks ago
Elk Grove Village, United States Ascension Health Full timeDetails * Department: Research * Schedule: Full Time, Day Shifts * Hospital: Ascension Alexian Brothers * Location: Elk Grove Village, Illinois Benefits Paid time off (PTO) Various health insurance options & wellness plans Retirement benefits including employer match plans Long-term & short-term disability Employee assistance programs (EAP) Parental...
-
Youth Sports Specialist
4 weeks ago
Maple Grove, United States i9 Sports - Northwest Metro Minneapolis Full timeJob DescriptionJob DescriptionBenefits/PerksA team-based atmosphere with a focus on Fun!Opportunity to build coaching skills and be a role model for athletesOnline training opportunitiesCompany OverviewFounded in Tampa, Florida, i9 Sports is the nations first and largest youth sports league franchise business in the United States with over 1 million...
-
Mental Health Client Relations Specialist II
3 weeks ago
Maple Grove, United States The Calli Institute Llc Full timeJob DescriptionJob DescriptionMental Health Client Relations Specialist IIIf you enjoy being a part of a team that makes a difference in the lives of others, then The Calli Institute is the place for you!Calli is looking for a Mental Health Client Relations Specialist II to work at our mid-sized, fast-paced, friendly and compassion-oriented mental health...
-
Sr. Product Development Engineer
3 days ago
Maple Grove, United States Cypress HCM Full timeA Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused...
-
Mechanical Engineer I
4 weeks ago
Maple Grove, United States Anteris Tech Full timeJob DescriptionJob DescriptionSalary: Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US;...
-
Quality Compliance Associate
1 week ago
Buffalo Grove, United States Clinical Resource Network (CRN) Full timeThe contract position performs specific duties within the area of commercial Quality Management System. The role performs quality review of API and finished product batch records, coordinates product complaint investigations, review vendor Deviations/CAPA, manage process change controls, and gather data to support Annual Product Review (APR) reports. Other...
-
Sr. Product Development Engineer
1 month ago
Maple Grove, United States Cypress HCM Full timeA Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused...
-
Sr. Product Development Engineer
1 month ago
Maple Grove, United States Cypress HCM Full timeA Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused...
-
Sr. Product Development Engineer
2 weeks ago
Maple Grove, United States Cypress HCM Full timeA Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused...
-
Sr. Product Development Engineer
1 month ago
Maple Grove, United States Cypress HCM Full timeA Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused...
