Hiring company: Orthofix
Why Orthofix?
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision “To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."
How you’ll make a difference?
The Clinical Trial Specialist (CTS) will collaborate with other Clinical Affairs personnel to initiate and maintain assigned site clinical studies. The Clinical Trials Specialist will be responsible for ensuring successful build and management of clinical studies to be audit ready at all times.
What will be your Duties and Responsibilities?
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Develop and maintain the electronic trial master file (eTMF) both site level and sponsor level.
Work with the Clinical Operations team (project management; CRAs) to track eTMF documents and notify them of expiring or missing documents.
Develop and maintain the study level tracking system for assigned study(s) (clinical trial master system – CTMS).
Responsible for upkeep of study outlook folder filing and organization.
Maintain Sunshine reporting database for clinical and preclinical projects.
Assist with distribution of study start up packets, which will include the review of document completion and accuracy.
Create study documents as assigned.
Prepare site supplies for shipment (regulatory binders; subject source binders; visa gift cards; IP).
Attend scheduled and ad hoc meetings.
Responsible for taking minutes and distribution of minutes for assigned study(s).
Assist with newsletter creation and distribution.
Corresponding with sites and IRBs.
Assist with IRB submissions, review of informed consents (ICF).
Perform other duties as assigned.
What skills you’ll need?
Bachelor’s Degree in a business administration, medical or scientific discipline equivalent experience.
2 years of supporting clinical trials and study managers
2 years of clinical trials experience
Excellent verbal and written communication skills
Detail-oriented self-starter who can work independently or as part of a team
Excellent computer skills using Microsoft Office, specifically Excel and Word
Ability to learn other computer programs (Oracle, etc.) to complete job duties
PHYSICAL DEMANDS AND WORK CONDITIONS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.