Job: Clinical Trials Associate, Shattuck Labs, Research Triangle Park, NC
Provide a brief summary describing the role, responsibilities and purpose.
Responsibilities include a variety of activities involved in support and application of clinical trials. Work as part of clinical team to assist the Clinical Trial lead and other clinical staff with operational needs across multiple clinical programs to optimize performance on clinical trial activities and ensure that trial activities are conducted in accordance with company SOPs, Good Clinical Practice, ICH Guidelines and all other regulatory requirements. The CTA may be responsible for providing trial document and systems management support to Clinical Trial Leads throughout trial startup, maintenance and closeout periods. In addition, the CTA will assist clinical teams with CRO and vendor oversight activities, data review, biosample reconciliation, tracking/ordering of investigational drug product and tracking of investigator payments.
KEY DUTIES AND RESPONSIBILITIES:
1 Assist clinical trial leads in management of the study operational plan, CRO oversight activities including IRB/EC application preparation and submission, vendor oversight, study timelines and recruitment plan to ensure high quality deliverables
2 Assist in the collection, review and approval of country specific and/or site-specific documents and/or essential regulatory documents. The CTA may upload and/or QC study documents, maintain all in-house trial files and assist with oversight of site files and trial master files.
3 Monitor trial progress to ensure compliance and proactively identify, evaluate and rectify problems. Assist clinical trial leads with clinical trial sites’ adherence to pertinent regulations through review of protocol deviations, monitoring reports, audit reports. Communicate with investigators, study site personnel, CRAs, and CRO personnel.
4 Assist with regular data review and data cleaning and preparation of slides for Safety Monitoring Committee (SMC) meetings. The CTA may assist in drafting SMC minutes and circulate to clinical trial teams for review prior to finalization.
5 Perform biosample tracking, reconciliation and query resolution. Manage shipments to affiliate labs. Work with Translational Medicine to facilitate in-house sample analysis.
6 Maintain an inventory of investigational drug product at drug depots and sites. Order investigational product and associated supplies based on site request.
7 Assist CTL with establishing a budget template, working with the clinical staff and/or CRO on the site budgets and payment schedule, providing budgetary information to clinical lead(s) and clinical staff; providing enrollment and other clinical updates to financing team for purposes of budgeting and investigator payments.
8 Maintain a working knowledge of, and ensure compliance with applicable ICG-GCP Guidelines, local regulatory requirements, and Shattuck SOPs and study specific procedures
9 Assist the CTL with keeping key stakeholders fully appraised of sites and study status. Schedules and attends internal and external meetings. May prepare and distribute meeting minutes and follow up with team members on action items.
QUALIFICATIONS & EXPERIENCE:
BA or BS in Life/Health Science
2+ years of clinical research experience in the pharmaceutical or biotechnology organization
Clinical trial (especially in oncology, early phase and/or immune therapy) experience is preferred
SKILLS & COMPENTENCIES:
Knowledge of clinical research concepts, practices, and GCP and ICH Guidelines
Excellent communication skills, collaborative style of working, strong attention to detail, organizational, interpersonal, problem solving skills, and the ability to work professionally and productively under pressure
Proficiency in Microsoft Office (Word, Excel, Power-Point), web-based systems, email and voicemail
Demonstrated experience in ability to perform several tasks simultaneously to meet deadlines, effectively prioritize and multitask.