Contract Clinical Research Associate – Accelerated Imaging Study (Short-Term Contract)
We are seeking one or more CRAs to support the US component of an international Prostate Cancer study. This is a focused, short-term engagement aimed at rapid site activation and a 3-month recruitment cycle.
The project is currently in the Site Qualification process with an aggressive goal to open sites in July. Qualified CRA(s) will manage sites in RTP (NC), Houston (TX), Oklahoma, and Cincinnati (OH). Monitoring will be primarily onsite (one site allows remote), with an onsite SIV, and low IMV frequency of 1–2 visits per site through December, concluding with close-out visits in the new year.
This role is ideal for a site management expert who prides themselves on data integrity and efficient Site Initiation. You will play a critical role in bridging the gap between histology reports and nuclear medicine scans, ensuring that source data matches the EDC perfectly. If you have a strong medical background or deep experience in med/surge/inpatient monitoring, we want to hear from you.
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive patient recruitment and enrollment tracking.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
- Ensure essential document collection for completeness per regulatory requirements.
- Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
Manage one or multiple studies. - Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Review in-house data and study tables.
- Mentor, coach and provide guidance to clinical staff as appropriate.
- Supervise and train other employees as appropriate.
- Must have at least 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a Sponsor (Imaging, Device, Pharma, or Biotech) or a CRO.
- Previous experience in quickly moving sites from initial qualification to SIV.
- Strong site management experience.
- Experience (in any capacity) with nuclear medicine tracers, radiography, or associated imaging processes.
- Proficiency in reading/understanding histology reports.
- It is a plus if you have experience monitoring inpatient or med/surg studies or if you have a medical background
- Must be located in one of their required locations in the US: NC, TX, OK, or OH. .
- Utilization is 25% and travel is required.