Career Opportunities

Assistant Regulatory Coordinator (Full-Time)

Compensation: 

$16/hr

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We are seeking the services of an onsite, full-time Assistant Regulatory Coordinator. Applicants must be very well-organized, adept with computers, diligent and have the ability to multi-task while still having a strong attention to detail.  Also, proficient in the use of Microsoft Office (Word, Excel) and other software.

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Objective

To assist the Regulatory Coordinator 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 Regulatory Coordinators 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.

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Duties and Responsibilities​

• Establish and maintain research files and documentation pertaining to regulatory requirements for clinical trials

• Provide regulatory support for new and ongoing research studies including 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

• Work closely with the Clinical Trial Coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date

• Attend weekly research team meetings and update 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

• Maintain research practices using Good Clinical Practice (GCP) guidelines

• Maintain strict patient confidentiality according to HIPAA regulations and applicable law

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Requirements

• 1-2 years experience in team support or administrative assistant capacity.  Strongly preferred in a medical, biotech, pharmaceutical company, or hospital setting.

• Experience in clinical research, specifically with regulatory processes, is strongly preferred.

• Proficiency in Word, Excel, and Adobe Acrobat

• Excellent organizational and administrative skills with 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

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

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This is a full-time position (40 hrs/week): Monday through Friday, 9:00am - 5:30pm.

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

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Opportunities for advancement to a Regulatory Coordinator (FT) position are available for those assistants who demonstrate strong aptitude and motivation.

On-Call Psychiatric Technicians (Part-Time)

Compensation:

DOE

We are seeking On-Call Psychiatric Technicians for our Clinical Research Unit (CRU).

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Duties and Responsibilities

• Assist nursing staff with oversight of admitted patients

• Note any changes in health or new health complaints

• Administer concomitant medications (if applicable)

• Conduct vital signs

• Assist with meals

• Notify research coordinator and/or doctors of any urgent issues

• Your shift may also involve patient admission or discharge where you will be performing a health status review and disposition of belongings

Qualifications

• Must possess a valid license

• Must be BCLS certified; ACLS preferred 

• Must be comfortable in working with a psychiatric population

• Must be able to communicate clinical observations and results to physician and clinical team 

• Experience in clinical research is a plus

• Available for day and/or evening shifts, 6 and/or 12 hour (Shifts: 1am - 7am, 7am - 1pm,  1pm – 7pm,  7pm -1am)

This job opportunity is great for anyone looking for extra income in addition to their current work schedule, as availability of shifts may vary. Compensation will be dependent on experience.

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

On-Call RNs and LVNs (Part-Time)

Compensation:

DOE

We are seeking on-call RN and LVN candidates for our Clinical Research Unit (CRU).

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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 offsite visits/walks, if applicable

Qualifications

• Must possess a valid nursing license

• Must possess personal nursing liability insurance

• Must be BCLS certified; ACLS preferred 

• Must be comfortable in working with a psychiatric population

• Experience in clinical research is a plus

• Available for day and/or evening shifts, 6 and/or 12 hour (Shifts: 1am - 7am, 7am - 1pm, 1pm – 7pm, 7pm -1am) 

• 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*]

Recent graduates are welcome to apply.

This job opportunity is great for anyone looking for extra income in addition to their current work schedule, as availability of shifts may vary. Compensation will be dependent on experience.

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