Job description

Title: Clinical Research Specialist - Investigator Initiated

Division: Client, Inc. (US01)

Location: Naples, FL 34108

**This position in based in Naples, FL. Relocation assistance available.**

· Client is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Client has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Client is actively searching for a Clinical Research Specialist to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

· Orthopedic surgeons are doctors who specialize in the musculoskeletal system - the bones, joints, ligaments, tendons, and muscles that are so essential to movement and everyday life. With more than 200 bones in the human body, it's an in-demand specialty. Dislocated joints.

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 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.

Education and Experience:

· Bachelor’s degree required.

· Familiarity with orthopaedic terminology is preferred

· 4 years of relevant clinical research experience required

· One year of industry sponsored or CRO employment

· Clinical Research Certification is required or obtains in one year.

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.

Job Type: Full-time

Pay: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Relocation assistance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Naples, FL 34108: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Speak with the employer
+91 7323985205

caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.