iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic industries. We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation. We do it all with a commitment to exceptional service.
We offer a comprehensive benefits package (medical/dental/vision/401k/PTO) and the opportunity to broaden your experience working with top level medical device and pharmaceutical clients to improve the quality of life for patients and consumers around the world.
We currently have an opening for a Study Startup & Essential Documents Specialist to join our Clinical team.
SUMMARY
The Study Startup and Essential Documents Specialist (SSEDS) is responsible for supporting site start-up activities, including collection and review of essential documents for assigned investigative sites and Central IRB activities on a project and site-level. As a member of the Clinical organization, the SSEDS is responsible for assigned clinical programs and sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manage essential documents at a study-level from study start-up through close-out and at a site-level from site selection through close-out inclusive of IRB activities
Complete activities to confirm study and site-level eTMF completeness and document quality
Responsible for Central IRB Management on a project and site-level
Complete Study-level IRB submissions inclusive of but not limited to:
Complete Site-level IRB submissions inclusive of but not limited to:
Independently accountable for study start-up for assigned clinical sites
Collect and carefully review essential documents in accordance with Sponsor specifications
Responsible for Essential Document Quality, Completeness, and Processing
Track site essential documents and maintain study trackers as assigned to provide real-time updates to Sponsor as requested
Primary point of contact for sites during the start-up process and essential document contact for the duration of the study (site activation forward)
Responsible for site-level essential document Action Item (AI) follow-up with sites (e.g., start-up/site activation documents, expired documents, missing documents, document updates) from the time of site-selection through site close-out
Collaborate with internal and external team members. Inclusive of but not limited to:
Read and adhere to client-approved or iuvo SOPs
Other duties as assigned
QUALIFICATIONS & REQUIREMENTS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE
COMPUTER SKILLS
COMMUNICATION SKILLS
This position requires a person who communicates effectively both verbally and in writing with clinicians, clients, vendors, and internal project team members through demonstration of:
Excellent presentation and interpersonal skills, including clear, succinct, and timely communication
Sharing ideas in a constructive manner
Listening to and objectively considering ideas and suggestions from others
Keeping commitments
Keeping others informed of work progress, timetables and issues
Read and comprehend work instructions/SOPs and protocols and write clear, concise communications and documentation
OTHER SKILLS and ABILITIES
PHYSICAL DEMANDS
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.
While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear.
WORK ENVIRONMENT and LOCATION:
This is a remote position. A suitable home office area is required. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
LOCATION Remote
TRAVEL As required, estimated as <5%.
DISCLAIMER
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
iuvo BioScience is an Equal Opportunity Employer