Our client, a leading medical devices company is hiring a Clinical Research Specialist.
Work Location: Naples, FL
- 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 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.
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.
- 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.
- Company-Provided Life Insurance
- Medical, Dental and Vision Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)