Clinical Research Nurse
Clinical Research Nurse
Posted on :
05-05-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-05-2025
Job Description
OVERVIEW
This role will lead the coordination of research in an exciting new environment with the full backing of a new type of research architecture and a toptier technology team challenging the paperheavy oldschool way that studies are run. Our Clinical Research Nurses are able to learn and grow rapidly and include the opportunity to help spearhead onsite efforts for Topographys partner healthcare groups. This role will be evaluated on practice success and metrics patient experience protocol management and adherence data quality and the ability to train retain and grow a highperforming team. This role will require a track record of excellence as both a nurse and researcher including developing successful relationships with providers. You should be comfortable seeing 5 patients a day and an independent problem solver. You will need to lead with empathy for patients build trust with a variety of stakeholders and care deeply about creating new access to clinical research in communities across the country.
KEY RESPONSIBILITIES
Manage all research personnel at the site while overseeing all site level research activities.
Act as a clinical trial lead to execute trials conducted within one or more physician practices including but not limited to:
Visit preparation activities
Visit followup activities
Supply and inventory management
Third party vendor management
Lead patient recruitment and enrollment of eligible patients across the portfolio of active trials
Oversee and conduct patient study visits which may also include clinical and lab procedures such as ECG phlebotomy vitals signs and body measurements laboratory processing etc.
Independently administer the informed consent process with care and quality
Ensure protocol adherence and high data integrity across site and study teams
Ensure high quality source data capture and documentation
Oversee study startup and planning including PSVs and SIVs
Oversee IRB submission and correspondence
Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the followup process and being the point of contact for monitors
IP management dispensation and accountability
Adverse Event management tracking and followup
Data entry to CRF/EDC and query resolution to meet stated contract obligations
Oversee study closeout including COVs
Protocol deviation tracking reporting and reconciliation including strategies to prevent repeat occurrence
Train and mentor junior research staff
Direct line management of site staff including Research Assistants CRCs and Senior CRCs
Using and helping improve Topographys proprietary tool set
Data Qualityunderstand and comply with all regulations policies and guidelines applicable to clinical research including our SOPs
Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation
Lead Quality Control activities including routine QC checks during and following study visits. Key to your role will be implementing processes and policies to increase data quality.
Project Management
Metrics and Practice Success. You will represent Topography and the research team locally at the practicelevel serving as an onsite clinical research expert and liaison to providers and practice management
Use a metricsdriven approach to organize the onsite team and maximize time on task
Success of the Team. You will be the daytoday leader of a growing team.
Achieve team goals with handson training coaching and mentorship
Create an efficient and positive work environment focused on our mission and the daytoday work required to achieve that mission.
Conduct necessary procedures such as blood draws injections and infusions.
You will be expected to cover all functions with a successful research program where necessary
Any other duties assigned by manager
MINIMUM QUALIFICATIONS
Bachelors degreeorequivalent combination of training and experience
Valid medical license
5 years of experience as a Clinical Research Coordinator Senior CRC and/or Research Assistant with other similar roles as additional experience
5 years of experience independently coordinating industry studies from study startup to close out
5 year track record of delivering clean data and a highquality patient experience
5 years demonstrated track record of creating success for a team and mentoring and leading colleagues to achieve discrete goals
5 years expert knowledge of FDA regulations and ICH/GCP guidelines
Experienced in both interventional and biomarker or observational clinical trials.
PREFERRED QUALIFICATIONS
Previous people leadership experience
Previous site level experience with sponsor and/or FDA audits
Experience in Phase 2 3 and 4 trials
$70000 $130000 a year
Base salary is only one piece of Topographys total compensation package which includes full benefits 401k bonus structure stock options flexible PTO top of market leave policy and more. Additionally we are able to be flexible for the right skill set and individual!
Employment Type
Full-Time
Key Skills
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