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.
As a full-service clinical research partner, with specific experience in ophthalmics. iuvo offers a variety of services in support of our clients’ clinical programs. We are looking for a Clinical Trial Associate to support various clinical trials.
The Clinical Trial Associate plays a key role in the clinical study team by providing operational support to ensure success of Oculos clinical trials. The CTA acts as the primary point of contact for investigative sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review data in EDC system in real time, issue and resolve queries.
- Document remote monitoring activities on appropriate report template.
- Provide supplemental EDC training for sites as needed.
- Maintain a level of accuracy that minimizes data query rate, identify data entry issues and trends, resolve said issues or escalate as appropriate.
- Willingness to conduct onsite monitoring visits as needed.
- Identify protocol deviations; re-educate sites to avoid further deviations.
- Identify high-risk sites and bring to the attention of Clinical Operations for additional training and/or correction action.
- Create project specific study logs and source document checklists and worksheets
- Interact with site staff to ensure smooth operation and documentation of trials under Good Clinical Practice (GCP) guidelines.
- Possess knowledge of the current study protocol(s), site monitoring plan, study manuals, Good Clinical Practices and Code of Federal Regulations and local country regulatory requirements.
- Remain current with applicable regulations concerning development and conduct of human clinical trials (FDA, ICH).
- Maintain clinical study documentation (e.g., eTMF, regulatory documents, etc.) including preparation for internal/external audits, final reconciliation and archival.
- Track IRB submission and renewal status.
- Track expiration dates of Medical Licenses, CVs, GCP training, EDC training and other documents, obtain updated documents and update eTMF as appropriate.
- Collect and review essential documents for accuracy and completeness (1572, CVs, medical licenses, etc.) as needed to assist Study Start-up Manager.
- Maintain productivity while working remotely.
- 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
- College degree preferred or equivalent work experience.
- Minimum of two years relevant work experience in clinical research operations, ophthalmology highly preferred
- Experience working with EDC systems
- Proficiency with Microsoft Office (Word, Excel, Outlook).
- Must be able to effectively communicate verbally and in writing with management, co-workers and clients. Read and comprehend work instructions/SOPs and protocols and write clear concise reports.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
OTHER SKILLS and ABILITIES
- Must be detail oriented, be able to effectively plan, organize, prioritize and problem solve.
- 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.