Internal Clinical Research Associate - Investigator Initiated

Arthrex, Inc. is global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Internal Clinical Research Associate. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Main Objective:

Assists the study team in running the day-to-day activities of clinical studies. Maintaining appropriate internal clinical study documentation and providing support for the clinical operational activities.

Essential Duties and Responsibilities:

• Provide support to study sites with site management activities.
• Coordinates and implements activities essential to successfully tracking approved research projects and updates Research Committee decisions on supported research projects in the Orthopedic Research department database.
• Responsible for maintaining Electronic Trial Master (eTMF) filing) systems, securing essential documents, and quality-checking files for accuracy and completeness as required.
• Sends all acceptance/ modification/ rejection communications to the Investigator-Initiated Research requestors upon the decision of the review committee.
• Supports incoming Investigator-Initiated Research Requests for completeness and communicates information gaps with the requestor to ensure all elements are addressed for timely review of proposals.
• Responsible for obtaining study status updates from study sites.
• Responsible for securing essential vendor documents for assigned clinical studies.
• Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.
• Responsible for ordering and distributing study products.
• Responsible for processing clinical research payments according to the signed agreement.
• Coordinates the development and updating of clinical research training guides, standard operating procedures, and work instructions.
• Participation in clinical trial team meetings, preparing agenda and distributing meeting minutes where required.  
• Identify and resolve study-related issues.
• Keeps management and Arthrex stakeholders informed on the progress of assigned clinical study metrics and other project-related information, specifically project approvals, publication status, costs, timelines, milestones, and other pertinent metrics.

Education and Experience:

• Bachelor’s degree + 1-year general experience or Master’s degree required.
• Sponsor or CRO level experience preferred.
• Familiarity with orthopedic terminology preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Good understanding and working knowledge of ICH guidelines and country regulatory guidelines. 
• Clinical Research Certification is required or obtained within one year.
• Comprehension of medical terminology or reference literature for understanding is preferred.
• Proficient software skills: Word/ Excel/ PowerPoint/database.

Machine, Tools, and/or Equipment Skills:

PC, database, research tools, internet research tools.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.