Study Start Up Specialist/Sr. Study Start Up Specialist

Ergomed•Raleigh, NC

4d•Remote

About The Position

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We partner with small to midsize biotech companies to move promising therapies through early phase development. The Study Start Up Specialist coordinates and oversees all activities related to achieving site activations in accordance with the contract, trial protocol and other study specific requirements, ICH-GCP, all applicable SOPs and regulatory requirements. This role takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process.

Requirements

Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
Minimum 5 years within pharmaceutical/CRO industry
Proven ability to successfully manage multi-country projects in start-up
Excellent organizational and management skills
Strong planning, strategizing, managing, progress monitoring, scheduling, problem-solving and critiquing skills
Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent self-motivation and motivation skills
Outstanding knowledge of ICH GCP across all areas
English both oral and writing
Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

Responsibilities

Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Serve as main point of contact for all project-specific Study Start-Up activities.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations.
Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation.
Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
Prepare study team reports or updates regarding status of essential document collection, review and approval.
Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI.
Assist with feasibility and site identification activities as needed.
Arrange for and/or review translation of essential documents as required.
Attend project team meetings and training sessions according to project and/or Sponsor requirements.
Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance.
Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
Support, mentor and train department staff and new-hires.
Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
Assist with development and implementation of trainings and SOPS/practice improvements.