CLINICAL RESEARCH PROJECT SPECIALIST
The GOG Foundation, Inc. (GOG Foundation) is a nonprofit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. Our institutions and investigators are essential contributors to advancements in treatment regimens, surgical procedures, quality of life analyses, and prevention knowledge. The results of GOG Foundation clinical trials have influenced the standard of care for numerous malignant gynecologic neoplasms.
Clinical trials research group seeks Clinical Research Project Specialist to work in Phila PA office to assist GOG Foundation/Partners operations team and provide support for study initiatives including:
KEY DUTIES AND RESPONSIBILITIES:
- Assist in development and review clinical study protocols, ICFs, CRFs, and other study-related documentation.
- Prepare and review regulatory documents for accuracy, compliance and submission on oncology clinical studies.
- Support site recruitment, feasibility and selection process for clinical trial participation.
- Attend Sponsor meetings and assist in planning and preparation of meeting agendas, minutes, and presentation materials.
- Maintain project documentation files.
- Manage external team communications including requests and reminders.
- Assist with preparation of progress reports, metrics, and surveys.
- Serve as a back-up to other team members for assigned project tasks and meetings as appropriate.
- Provide support to investigators and site staff to address questions and concerns.
- Perform data entry tasks.
- Provide administrative support for multiple projects simultaneously.
- Bachelor’s Degree preferred or relevant work history.
- Recent data management, clinical research associate or contract research organization experience required
- Knowledge of Code of Federal Regulations with experience specifically with FDA regulations, OHRP regulations, ICH and GCP guidelines required
- Strong organizational skills
- Strict attention to details
- Experience with Outlook, MS Word, Excel, PowerPoint
- Excellent writing and verbal communication skills
- Excellent data entry skills required
- Ability to perform at a high level in a fast-paced and collaborative environment, work independently, take initiative, balance workload, and prioritize assigned tasks
This is a position in the GOG Foundation Administrative Office located in Philadelphia, PA.
Currently, the staff is working remotely on a temporary basis.
Posting ID: 600959902Posted: 2021-01-22