- Participates in overall department strategy to provide clinical data needed for regulatory submissions, publication, and supporting clinical site coordinators.
- Manage Investigator-Initiated clinical research studies.
- Evaluates and analyzes clinical data.
- Collaborate with key opinion leaders to identify issues or barriers related to the research request execution.
- Lead required cross-functional research meetings to discuss studies and get input from product managers.
- Track and report on the progress of assigned clinical studies, including budget and timelines.
- Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
- Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in the A/P system within compliance guidelines.
- Manage data collection compliance via tracked milestones.
- Responsible for the execution of clinical projects while adhering to budget, scope and schedule requirements.
- Lead clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements.
- Lead clinical budget negotiations for the purpose of executing a clinical study.
- Assist site coordinators with IRB submissions as necessary.
- Shows initiative to identify and implement ways to improve jobs and surroundings.
- Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP's and Standard Operating Procedures.
- Maintain a high level of professional expertise through familiarity with scientific literature and product portfolio.
- Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment. Build and maintain excellent working relationships with clinical site staff, key opinion leaders and colleagues.
- Bachelor's degree required.
- Familiarity with orthopedic terminology is preferred
- 4 years of relevant clinical research experience required
- One year of industry sponsored or CRO employment preferred
- Clinical Research Certification is required or obtains in one year.
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Relocation assistance
- Tuition reimbursement
- Vision insurance
- 8 hour shift
- Monday to Friday
-
Clinical Research Specialist
1 week ago
Arthrex, Inc. Naples, United StatesRequisition ID: 59790 Title: Clinical Research Specialist - Investigator Initiated Division: Arthrex, Inc. (US01) Location: Naples, FL · This position in based in Naples, FL. Relocation assistance available. · Arthrex is a global medical device company and leader in research, new ...
-
Clinical Research Specialist
1 week ago
Arthrex, Inc. Naples, United StatesTo collaborate with clinical site coordinators on Investigator-Initiated clinical research studies from site start-up to the last follow-up visit. Essential Duties and Responsibilities: Participates in overall department strategy to provide clinical Clinical Research, Clinical, R ...
-
Clinical Research Specialist
2 weeks ago
Arthrex Naples, United StatesRequisition ID: 59790 Title: Clinical Research Specialist - Investigator Initiated Division: Arthrex, Inc. (US01) Location: Naples, FL · **This position in based in Naples, FL. Relocation assistance available.** · Arthrex is a global medical device company and leader in researc ...
-
Clinical Research Specialist
2 weeks ago
TSR Consulting Naples, United StatesJob ID: 78609 · Job description · Main Objective: · To collaborate with clinical site coordinators on Investigator-Initiated clinical research studies from site start-up to the last follow-up visit. · Essential Duties and Responsibilities: · Participates in overall departmen ...
-
Clinical Research Specialist- IIR
3 weeks ago
TSR Consulting Naples, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of co ...
-
Clinical Research Specialist- IIR
2 weeks ago
TSR Consulting Naples, United StatesAbout TSR: TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of compan ...
-
Accounts Payable
2 weeks ago
Premier Sotheby's International Realty Naples, United StatesPremier Sotheby's International Realty is the luxury leader in the markets we serve with over 40 offices across NC and FL. · We are seeking an experienced AP Specialist to join our Accounting team at our beautiful Park Shore office in Naples. We offer an excellent full benefits p ...
-
Remote Lighting Design/specifier Assistant
3 weeks ago
Liaison Technology Group Naples, United StatesLighting Specialist/Specifier Assistant · Job Summary: · Do you have a passion for excellence in home and business technology? Do you love to problem solve? Do you love to learn? Do you want a path to greater responsibilities, authority and compensation? If this is you then Liais ...
-
Remote Window Treatment Designer
1 week ago
Liaison Technology Group Naples, United StatesLighting Specialist/Specifier Assistant · Job Summary: · Do you have a passion for excellence in home and business technology? Do you love to problem solve? Do you love to learn? Do you want a path to greater responsibilities, authority and compensation? If this is you then Liais ...
-
Medical Asst Primary Care Ne
1 week ago
NCH Healthcare System Naples, United States Full time**DEPARTMENT**: Northeast**LOCATION**: 15420 Collier Blvd, Naples, FL, 34120**WORK TYPE**: Full Time**WORK SCHEDULE**: 10 Hour Day** · $5,000 Sign on Bonus** · **ABOUT NCH** NCH is an independent, locally governed non-profit delivering premier comprehensive care. Our healthcare s ...
-
Medical Billing Specialist
1 week ago
Skin Wellness Physicians Naples, United States**Benefits**: · - 401(k) matching · - Bonus based on performance · - Company parties · - Dental insurance · - Employee discounts · - Health insurance · - Opportunity for advancement · - Paid time off · - Parental leave · - Training & development · - Vision insurance · The Medical ...
-
Property Acquisition Specialist Ii
1 week ago
Collier County, FL Naples, United States**Job Summary**: · Performs highly complex technical work related to the acquisition and sale of real property. · **Essential Functions**: · - Performs complex research and investigations on property being considered for purchase or sale by the County. · - Research public records ...
-
B2b Inside Sales Specialist, Ft
1 week ago
Sunshine Ace Hardware Naples, United States**Business to Business Inside Sales Specialist** · **Full Time** · **Naples**, FL** · Our family-owned business has been providing career opportunities and adding economic value to our local economy since 1958. Our customers have come to depend on the helpful advice our friendly ...
-
Inventory Specialist Ft
6 days ago
Winn-Dixie Retail Stores Naples, United StatesOverview: · - Southeastern Grocers is committed to a culture of belonging and fostering an inclusive environment where we celebrate differences. As a _great place to work_, we empower everyone to be their full, authentic selves. Read our _Belonging, Inclusion and Diversity Statem ...
-
Chief Psychologist
3 weeks ago
Phoenix Innovations Naples Park, United States* As a leading psychologist (m/f/d) in permanent employment, you will be responsible for the care of patients in individual and group settings, as well as in interdisciplinary teams and indicative group programs in Naples Park. · * You will lead and shape the further education of ...
-
Retail Book Specialist
1 week ago
Goodwill Industries of Southwest Florida Bonita Springs, United States**GOODWILL INDUSTRIES OF SOUTHWEST FLORIDA, INC.** · **Retail Book Specialist** · Full time · **_ Location: Springs Plaza #123_** · Based in Fort Myers, Florida, Goodwill of Southwest Florida is committed to serving people with disabilities and disadvantages by offering life-chan ...
-
Medical Laboratory Technician
3 weeks ago
Florida Cancer Specialists, P.L. Naples, United StatesDate Posted: · Country: · United States of America · Location: · Naples West Office · WHY JOIN FCS · At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communi ...
-
Medical Laboratory Technician
3 weeks ago
Florida Cancer Specialists, P.L. Naples, United StatesDate Posted: · Country: · United States of America · Location: · Naples Pine Ridge Office · WHY JOIN FCS · At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and c ...
-
Florida Cancer Specialists Naples, United StatesDate Posted: · Country: · United States of America · Location: · Naples Goodlette Office · WHY JOIN FCS · At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people ...
-
Licensed Practical Nurse
3 weeks ago
Florida Cancer Specialists Naples, United StatesDate Posted: · Country: · United States of America · Location: · Naples Pine Ridge Office · WHY JOIN FCS · At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the peopl ...
Clinical Research Specialist - Naples, United States - TSR Consulting Services, Inc.
Description
Job ID: 78609
Job description
Main Objective:
To collaborate with clinical site coordinators on Investigator-Initiated clinical research studies from site start-up to the last follow-up visit.
Essential Duties and Responsibilities:
Education and Experience:
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong communication, documentation, and record-keeping skills are required. A basic ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required. The ability to read surgical techniques and have a basic understanding of the instruments necessary to perform the procedure is preferred. Attention to detail and the ability to review protocols and agreements for accuracy are required. The ability to work as a team and contribute to the goals of the group, department, and company is required.
Machine, Tools, and/or Equipment Skills:
Experience in Microsoft Office is required. Experience with clinical trial databases (EDC, CTMS, eTMF) is required.
Reasoning Ability:
Ability to prioritize and manage multiple tasks. Ability to solve problems and deal with numerous variables.
High attention to detail and the ability to edit documents.
Job Types: Full-time, Contract
Benefits:
Schedule:
Work Location: In person
