Study Startup Specialist I

CenExel•Savannah, GA

1d•Onsite

About The Position

Under moderate supervision, the Study Start Up Specialist I is responsible for initiating and implementing study start up activities for the daily operational and administrative functions of clinical study operations with a focus on project and resource management. Ensures the implementation of policies and procedures of site and regulatory agencies are met or exceeded.

Requirements

Must be able to effectively communicate verbally and in writing.
Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines and regulations.
One year of experience in clinical research.
Strong customer service and client relationship skills.
Excellent organization and time management skills with strong ability to prioritize and multi-task across competing demands.
Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions.
High-level computer skills.

Responsibilities

Ensures that assigned start-up activities are on track and in accordance with client and internal expectations.
Inventories, logs, and organizes study materials received during study start up.
Distributes study materials to delegated individuals while maintaining accountability for the transfer of supplies.
Collaborates with clinical staff to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes.
Communicates with external vendors including contract research organizations, sponsors and monitors on behalf of clinical staff.
Review clinical study documentation in adherence to protocol, ensuring compliance.
Participates in formal training of study staff prior to first subject screening.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.