Career Opportunities

Clinial Research Unit (CRU) Nurse [RNs, LVNs]

Compensation:

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DOE

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*Health, dental, and vision insurance, 401(k), and other benefits are available for eligible full-time employees.

NRC Research Institute is offering RN, LVN, and LPT candidates an exciting opportunity for full-time and/or part-time employment in our inpatient Clinical Research Unit. This is a contractual employee position, based on actively enrolling inpatient clinical trials. Candidates will be assigned a set schedule upon hire, based on 6-hour shifts or 12-hour shifts. This position includes Medical Benefits as well as Paid Time Off.

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Duties and Responsibilities

• Monitor human research subject(s) and communicate clinical observations and results to physicians and the clinical team

• Administer investigational drug and other concomitant medications to subject(s)

• Assist with meals and other daily allowance distribution

• Perform admission and discharge procedures, as needed

• Accompany/escort subject(s) for off site visits/walks, if applicable

Qualifications

• Must possess a valid RN, LVN, or LPT license

• Must be BCLS certified; ACLS preferred

• Must be comfortable in working with a psychiatric population

• Experience in clinical research is preferred but not required

• Evidence of GCP (Good Clinical Practice) and HRP (Human Research Protections) training certification is required but may be completed upon hire, if needed [*Training stipend provided*]

Position Type:

FULL-TIME:  This is a Full-time, contractual employee position based on actively enrolling inpatient clinical trials. Full-time is considered a minimum of 36 hours per week, based on 6-hour shifts or 12-hour shifts. This position includes Medical Benefits as well as Paid Time Off (up to 5 days of PTO and 3 days of Paid Sick Leave annually).

PART-TIME:  This is a Part-time, contractual employee position based on actively enrolling inpatient clinical trials. Part-time is considered 12-30 hours per week, based on 6-hour shifts or 12-hour shifts. This position includes 3 days of Paid Sick Leave annually.

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The set shift schedule is as follows:

Monday - Sunday:  7:00 pm- 1:00 am,  1:00 am - 7:00 am  (6 hr or 12 hr shift options)

*​Applicants with availability for 12 hours shifts is preferred. 

When applying for this position, please attach a copy of your resume and current license.

Clinical Research Coordinator (CRC) Experienced

Compensation:

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$50-80k DOE

*Health, dental, and vision insurance, 401(k), and other benefits are available for eligible full-time employees.

NRC Research Institute has been conducting clinical trials for the world’s pharmaceutical firms since 2004. We specialize in pharmaceutical clinical trials involving CNS (Central Nervous System) disorders such as Schizophrenia, Bipolar Disorder, Depression, ADHD, Autism, and more. We are looking for an energetic and experienced Clinical Research Coordinator (CRC) to join our team.

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The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Principal Investigator and Scientific Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring a high level of knowledge of study specific protocols, as well as coordination and collaboration with research colleagues and departments.

Job Duties:

• Perform study procedures in accordance with GCP and study protocols
• Coordinate protocol related research procedures, study visits, and follow-up care
• Organize and maintain paper and electronic study data in a complete and correct manner
• Work closely with recruitment and prescreening teams to meet study enrollment goals
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Maintain study source documents
• Report adverse events
• Educate subjects and family on the protocol, study intervention, study drug, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Complete case report forms (paper & electronic data capture) and address queries
• Facilitate study initiation, monitoring visits, and close out activities
• Retain records/archive documents after study close out
• Requires effective writing and communication, work as part of a team, ability to multitask
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Document investigational product (drug/device) accountability

Qualifications:

• Minimum one year of comprehensive pharmaceutical clinical research coordinator experience
• Bachelor’s Degree and/or healthcare licensure/certification required; degree in Biology and/or Psychology field preferred
• Must be willing and able to work in a clinical setting involving a psychiatric/mentally disabled population
• Must have ability to read and understand clinical trial protocols
• Must have attention to detail and the ability to handle multiple tasks with precision
• Must be adept with computers
• Must possess excellent critical thinking skill
• Must have excellent interpersonal and communication skills and be a hardworking team player
• Must possess strong data management skills
• Familiarity with medical terminology/environment required

This is a full-time onsite position (40 hrs/week). Hours are Mon-Fri, 9:00 am - 5:30 pm

Regulatory Coordinator, Entry-Level

Compensation:

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$23/hr

*Health, dental, and vision insurance, 401(k), and other benefits are available for eligible full-time employees.

NRC Research Institute is seeking the services of a full-time on-site Entry-Level Regulatory Coordinator.

Applicants must be very well-organized, adept with computers and diligent, with the ability to multi-task while still having a strong attention to detail, and proficient in the use of Microsoft Office (Word, Excel) and other software.

OBJECTIVE: To maintain accurate and essential documents to ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA), local Institutional Review Board (IRB), pharmaceutical sponsors, and any other regulatory agencies. Work closely with senior Regulatory Coordinator as well as investigators, clinical trial coordinators, and other research staff to assure that all regulatory documents for the research studies are met and up-to-date, including but not limited to IRB submissions/approvals, study-specific regulatory documents, and staff certifications and CVs. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial.

Essential Job Duties and Functions:
- Prepares and submits protocols and supporting documents to regulatory bodies, including various IRB
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies
- Responds to all questions from the IRB or related to the regulatory aspects of the study
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies
- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials
- Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators and study file documentation creation and maintenance
- Help to ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies
- Organize and store protocol files including but are not limited to: all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions
- Assist in maintenance of regulatory-related internal tracking databases and filing systems
- Ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOA). Ensure in conjunction with the DOA that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder
- Ensure all necessary forms are submitted to the trial sponsor and the IRB
- Meets with monitors from pharmaceutical companies as a representative of the research site during these visits
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date
- Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments
- Help to ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board
- Maintains research practices using Good Clinical Practice (GCP) guidelines
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law

Requirements:
- Bachelor’s Degree preferred
- 1-2 years’ experience in team support or administrative assistant capacity, preferably in a medical, biotech, pharmaceutical company, or hospital setting is strongly preferred
- Experience in clinical research, specifically with regulatory processes, is strongly preferred
- Proficiency in Word, Excel, and Adobe Acrobat
- Excellent organizational and administrative skills and a superior attention to quality and detail
- Excellent time management skills and written and verbal communication skills with a variety of individuals
- Ability to work independently as well as in a team environment
- Proven ability to multi-task and prioritize duties of varying skill levels, and to focus on and adapt to changing priorities
- Energetic, positive, flexible, and team-oriented
- Must be articulate, proactive, responsive to deadlines, detail-oriented, and able to prioritize multiple tasks

Upon the successful completion of a minimum 90-day period, employee will be eligible for medical and dental benefits and may also qualify for wage increase.

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Full-time (FT) applicants only / 40 hrs/wk required. Hours are Mon - Fri, 9:00 - 5:30 pm

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Position immediately available. This position requires employee to work ONSITE, not WFH.