Clinical Trial Specialist

Description

JOB SUMMARY:

Under general supervision, develops, coordinates, and administers the logistical aspects of clinical trials according to good clinical practice (GCP), good documentation practices (GDP) and standard operating procedures (SOP). Acts as a pivotal point of contact and communication between department staff, clinical sites, as well as vendors. 

KEY RESPONSIBILITIES:

1. Oversee and manage operational aspects of clinical trials in conjunction with project teams and in accordance with SOPs, GCP, GDP and specific country regulations, and may prepare clinical trial budgets. 

2. Collaborate and partner with a cross-functional team which includes clinical field, site managers, monitors, safety, and others. 

3. Build and maintain optimal relationships and effective collaborations with various internal and external parties. 

4. Develop, test, and implement clinical tools to provide relevant information for clinical studies management. 

5. Manage clinical study site information and documentation.

a. Request, track, review and assure receipt of proper study documentation (IRB approval letters, Signature Pages, Informed Consent materials, signed Clinical Study Agreements, Confidentiality Agreements, etc.).

b. Obtain, review, and file site personnel documentation to ensure site compliance.

c. Develop and distribute clinical study documents (Protocol, Case Report Forms, Informed Consent, Agreements, etc.).

6. Routinely correspond with clinical study sites.

a. Provide timely support as subjects go through the screening process.

b. Promptly answers sites’ questions and requests with accuracy.

c. Generate and submit memos and study documents (protocol amendments, newsletters, brochures, etc.) to clinical study sites.

d. Generate, review, and respond to queries the electronic data capture (EDC).

7. Coordinate all information regarding adverse events and ensure all information is received by the internal team and clinical study sites. 

8. Maintain accurate records and files of study patient data. Coordinate accurate completion of Case Report Forms in EDC by timely reviewing them and corresponding with sites to update data and/or creating corrective action plans. 

9. Coordinate on-site and off-site Investigator, Study Coordinator and Technologist training meetings and conference calls. 

10. Provide support to monitoring staff by creating monitoring visit prep packages, answering monitors’ questions during visits, and reviewing monitoring visit reports.

11. Order, assemble, and maintain supplies of study materials and equipment (handbooks, Case Report Form books, IDE copies, medical equipment, etc.).

12. Other duties, as assigned by supervisor and/or clinical research project managers. 

Requirements

 EDUCATION:

Bachelor’s degree in engineering, biology, physical sciences, nursing or another related field.

PREFERRED EXPERIENCE:

One plus years of experience in clinical/medical affairs in the medical device industry.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of medical terminology and anatomy.
• Knowledge of FDA guidelines and regulations governing conduct of clinical trials.
• Detailed knowledge of the documents required for a Regulatory Binder (IRB approvals, Investigator Agreements, CVs, MLs).
• Strong organizational skills and detail orientation required. 
• Interpersonal and communication skills necessary to interact with study site personnel and physicians.
• Analytical skills to determine clinical requirements and evaluate software solutions.
• Intermediate skills in Microsoft Office, Word, and Power Point.
• Advanced skills in Excel, Access, and clinical database software. 
• Ability to handle multiple priorities in a fast-paced environment.
• Ability to make independent judgments. 
• Ability to travel as needed up to 20%.