In-House Clinical Research Associate (IHCRA)
About Inhibikase
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH).
In-House Clinical Research Associate (IHCRA)
We are seeking a dynamic individual in the role of an in-house Clinical Research Associate to support and manage start-up and execution activities of clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. Reporting directly to the Global Trial lead (Sr. Clinical Trial Manager and above). The In-house Clinical Research Associate (IHCRA) supports the clinical trial by managing and oversee clinical study site activities. This role will serve as Inhibikase primary liaison with the clinical study sites and contribute to building a culture of team, site and patient centricity. This role is accountable for clinical site activities from site identification through close out of the study site. The CRA has ‘in-house’ responsibilities (e.g., management/oversight of vendors, enrollment tracking, data tracking), and as required by project scope, performs visits at the clinical study sites (e.g., oversight activities, co-monitoring visits). The IHCRA, under the direction of the Global Trial Lead independently collaborates with the Clinical Trial Manager and/or Site Monitor.
Responsibilities
In-house responsibilities
- Assists and contributes to the development of study documents (e.g., protocols, case report forms, informed consent forms)
- Assist with the development and implementation of project specific processes, tools, and documents (e.g., annotated visit reports, site email templates, site trackers)
- Coordinate or manages, either directly or through supervised delegation, study-wide activities such as external vendors, recruitment efforts, sample handling, data review, and Trial Master File review
- Assist with the identification and selection of appropriate clinical trial sites and investigators
- Supports field based CRAs to provide them EDC metrics to manage site’s data entry and query resolutions
- Support site engagement with the site and serve as a site liaison
- Supports and contributes to eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
- Participate in internal and external study team meetings
- Assist with investigator meeting preparations, including the creation of training materials for both CROs and clinical study sites, and helps coordinate the investigator meeting planning and logistics
- Assist with tracking study metrics (e.g., monitoring KPIs) for report to management
- Reviews CRO site visit reports and generates oversight visit reports;
- Performs oversight on CROs monitoring activities including the resolution of action items and protocol deviations
- Oversee CROs monitoring metrics inclusive of SDV data
- May support some aspects of study level vendor management
- May support study team on some aspects of internal clinical data review
Field monitoring responsibilities
- May attend oversight monitoring visits to evaluate site and site monitor performance
- May support routine study visits as needed to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines
- May review and ensure data integrity, accuracy, and completeness at the clinical study sites
- Escalate site related issues to the study team
- Ability to travel up to approximately 25%
Education and Training
- Bachelor's degree or higher, with 4-6 years of experience with at least 1 year working in biotech/CRO in a similar or lesser role
- Experience with on-site or remote monitoring experience desired
- Experience working in a fast-paced and dynamic environment
- Certification as a Clinical Research Associate (CCRA) or equivalent a plus
- Knowledge of therapeutic areas relevant to Inhibikase’s portfolio a plus
Skills and Abilities
- Working knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
- Knowledgeable with the CDISC TMF reference model
- Good communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
- Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
- Proficient computer skills and standard Microsoft Office Suite (Word, Excel, PowerPoint)
- Knowledgeable of clinical trial processes and study conduct
- Excellent organizational and time management skills
- Strong critical thinking and problem-solving skills
- Detailed oriented
Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.
Please send resumes and expression of interest to: careers@inhibikase.com
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