Clinical Research Nurse

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 top-tier technology team, challenging the paper-heavy, old-school way that studies are run. Our Clinical Research Nurses are able to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography’s 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 high-performing 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 follow-up 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 start-up and planning, including PSVs and SIVs

Oversee IRB submission and correspondence

Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process and being the point of contact for monitors

IP management, dispensation and accountability

Adverse Event management, tracking, and follow-up

Data entry to CRF/EDC and query resolution, to meet stated contract obligations

Oversee study close-out, 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 Topography’s proprietary tool set

Data Quality-understand 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 practice-level, serving as an on-site clinical research expert and liaison to providers and practice management

Use a metrics-driven approach to organize the on-site team and maximize time on task

Success of the Team. You will be the day-to-day leader of a growing team. 

Achieve team goals with hands-on training, coaching, and mentorship

Create an efficient and positive work environment, focused on our mission and the day-to-day 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

Bachelor's degree or equivalent 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 high-quality 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