Clinical Trials Specialist

Clinical Trials Specialist

Background:  Axial Biotech is revolutionizing spine care by developing molecular diagnostics and motion preserving surgical implants. Axial will transform current treatment paradigms by using its predictive tests to bring motion preserving technologies to the widest range of patients at the earliest appropriate stage.

 

Job Description

The successful candidate will coordinate and monitor the activities associated with the evaluation, initiation and management of FDA clinical trials. Communicates with sites and resolve inquires and problems related to clinical investigation. Assists with obtaining required legal, ethical and technical agreements with sites participating in studies.

Provide clinical data when needed for presentations, monographs and publications. S/he will develop study tools for implementation and tracking of study activities. Oversee, review and approve case report forms, investigator qualification reports, site initiation reports, and monitoring reports. Maintain a high level of professional expertise through familiarity with clinical literature and participation in project meetings.

 

Duties / Responsibilities:

1.  Quality assurance and quality control for FDA clinical trial submission

2.  Monitors clinical studies regulating GCP, company SOPs and FDA guidelines for clinical trials; ensures timely enrollment against plan

3.  Confirms the accuracy of administrative data

4.  Assists in the identification of clinical investigators

5.  Assists in the preparation of Investigator Meetings

6.  Tracks essential documents to ensure they are received and maintained.

7.   Independently administer patient screening, patient eligibility and protocol deviation issues

8.  Ensures adverse events are reported properly and follow-ups done in a timely manner

9.  Prepares study documents (consents, site instructions, etc)

10.  Assists in the design, format and content of CRFs study guides and subject instructions

11.  Prepares summary reports, call logs, and general administrative support for department.



Qualifications

· Must possess BA/BS in biological sciences or related field, or RN

· Three (3) years work experience in life science or medically related field including two (2) years clinical research experience (eg, CRA, study coordinator)

Required Skills for Regulatory Affairs Specialist

· Must have a thorough understanding of GCPs, CFR and ICH guidelines.

· Outstanding oral and written communication skills

· Strong interpersonal skills

· Attention to detail and follow-through

· Knowledge of device and pharmaceutical clinical development

· Experience in a supervisory role an asset

· Good organizational and planning skills

· Good comprehension of Good Clinical Practices and regulatory requirements

· Good knowledge of the concepts of clinical research and diagnostic test development

· Computer and system operation skills

· Strong problem-solving skills

· Ability to influence clinical site staff in a positive manner

 

 

Principals only.  Recruiters please don’t contact this job poster.