Clinical Trial Specialist II

United Therapeutics Corporation•RTP, NC, NC

7d•Onsite

About The Position

The Clinical Trial Specialist II partners with global clinical study teams to lead investigator-site contact during assigned study start-up activities. Under general supervision, the specialist works independently to develop strategies for efficiently collecting and reviewing study start-up documents, including essential regulatory documents, and supports study start-up in accordance with established practices. The role also maintains the responsibilities of the Clinical Trials Specialist I with a high degree of proficiency, accuracy, and autonomy. The specialist coordinates start-up activities through completion of the initial critical document package. Responsibilities include feasibility activities and investigator selection; support for local regulatory and IRB/IEC submissions; customization and review of informed consent forms; collection, review, and approval of essential documents; development of study-specific materials and templates; and management of applicable Central IRB/IEC vendor activities. The role supports inspection readiness, coordinates translation needs, monitors start-up timelines and site information, and maintains accurate communications with internal and external study teams. The specialist may also assist with SOPs, training processes, clinical trial correspondence, and mentoring junior staff. This is an onsite role based in United Therapeutics’ RTP, North Carolina office, requiring five days per week in the office.

Requirements

Bachelor’s degree.
At least 3 years of experience in clinical study start-up or equivalent clinical research experience, such as Clinical Research Associate, Clinical Research Coordinator, or Clinical Trial Management, with significant and increasingly independent interaction with corporate functional units.
Prior experience using clinical system technology such as SSU, eTMF, or CTMS.
Working knowledge of ICH/GCP guidelines in a clinical environment, including essential clinical trial documents.
Strong organizational skills and ability to multitask and prioritize in a fast-paced environment.
Exceptional attention to detail and accuracy.
Effective written and verbal communication skills.
Creative and proactive problem-solving skills.
Demonstrated self-starter with a high level of commitment.
Strong customer service orientation.
Competency using Microsoft Office software, including Word, Excel, Outlook, and PowerPoint.
Ability to communicate effectively, in writing and orally, with colleagues and management within and outside Clinical, including upper management, vendors, clinical investigators, and site personnel.
Ability and commitment to manage high workloads, demanding situations, and deadlines.

Nice To Haves

At least 5 years of experience in clinical study start-up or equivalent clinical research experience, such as Clinical Research Associate, Clinical Research Coordinator, or Clinical Trial Management, with significant and increasingly independent interaction with corporate functional units.

Responsibilities

Maintain Clinical Trials Specialist I responsibilities with proficiency, accuracy, and autonomy.
Coordinate and guide study start-up activities through completion of the initial critical document package.
Develop, perform, and track feasibility activities to aid investigator selection.
Support investigators and site staff with local submissions in accordance with local regulatory and IRB/IEC requirements.
Assist with customization, review, and configuration of country- or site-specific informed consent forms.
Collect, review, and approve initial essential documents in accordance with sponsor and investigator obligations, local regulatory requirements, and ICH/GCP guidelines.
Create study-specific manuals, tools, and templates, including investigator site files and subject materials.
Develop and maintain master informed consent form templates and revisions throughout the study.
Develop, monitor, and maintain initial start-up packages and essential regulatory document templates.
Manage the Central IRB/IEC vendor, when applicable, and maintain study-level documents and approvals throughout the clinical study.
Maintain inspection preparedness by keeping study and site milestones current in appropriate systems and ensuring contemporaneous filing in the Trial Master File, as applicable.
Identify and organize translation needs and coordinate with translation vendors and study/site teams to obtain necessary documents.
Monitor study and site start-up timelines, and provide alternative dates and strategy recommendations to study teams and leadership when needed.
Maintain accurate site demographic and status information in applicable systems and tracking tools.
Ensure timely and accurate study-related communication with internal and external study teams, including CRO and site personnel.
Assist in developing SOPs and managing departmental manuals, tools, and training processes.
Serve as a liaison with the CPM, CTC, and other clinical study team members.
Assist with preparing and distributing clinical trial correspondence and newsletters.
May guide and mentor more junior-level staff.
Maintain current knowledge of the field through published materials, industry meetings, and relevant coursework or seminars.