Be Part of the Solution

At RCR, we are a team-based organization, emphasizing the value and importance of all employees regardless of their specific roles or the simplicity and complexity of the tasks that they perform.

Position Summary

Ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Essential Job Functions

  • Employee Mentoring
  • Protocol Planning and Oversight
  • Investigator Qualifications and Agreements
  • Ensure Protocol Compliance
  • Ensure Adequate Review by A Duly Constituted Institutional Review Board (IRB)
  • Manage the Care of Subjects
  • Protect the Rights and Welfare of Subjects
  • Ensure Validity of The Data Reported to The Sponsor
  • Ensure Documentation of Study-Related Procedures, Processes and Events
  • Ensure the Proper Use and Storage Of Investigational Agents
  • Study Communication
  • Business Development
  • Maintains Professional and Technical Knowledge

M.D, D.O., or PhD required

Learn more about being a provider at RCR here.

Position Summary

Expert on assigned trials as the Lead Study Coordinator where they are responsible for ongoing, active communication of study progress and questions. Oversees all aspects of the trial. Delegates tasks appropriately and ensures all appropriate staff have necessary training. Preforms study visits.

Essential Job Functions

  • Lead Study Coordinator on 4-8 trials at a time
    • Be an expert on assigned trials, overseeing all aspects of the trial with oversight by the PI
    • Responsible for ongoing, active communication of study progress, questions, issues with Investigator and sub-investigator
    • Lead Study Review on assigned trials
    • Ensure appropriate staff have all necessary documented training on assigned trials
    • Ensure RCR delegation of Authority log has been signed doff appropriately prior to individuals prior to performing study-related tasks
    • Ensure study source documents for assigned trials reflect all necessary data points per protocol and data capture system, using the RCR template and process (clerical assistance) including inclusion/exclusion and appropriate involvement of PI and in conjunction with QA director template and review
    • Ensure all study supplies for assigned trials are received and sufficient for study goals
    • Ensure study drug is dispensed, accounted for, and returned to the Sponsor per protocol
    • Act as the Sponsor’s monitor primary site contact
    • Ensure SAE’s are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) in a timely manner, collect all information to report the event, follow up appropriately
    • Ensure complete and timely review of all study procedures
    • Responsible for delegating work, outcomes, and general oversight of their assigned Research Assistant
  • Perform study visits
  • Accurately complete study sources for any of the site’s ongoing studies once delegated and trained on the protocol prior to performing study-related tasks

2 years of clinical nursing experience required. Strong clinical background with evidence of independent clinical assessment skills and strong attention to detail preferred.

RN/ LPN from 2, 3, or 4-year program is required.

CCRC preferred not mandatory at the time of hire.

Position Summary

Performs all delegated support tasks for the Study Coordinators. Ensure quality and timely data entry as well as preparation of charts. Conduct Quality Assurance / Quality Control review of patient data to ensure accuracy.

Essential Job Functions

  • Perform delegated support tasks for Study Coordinators
    • Chart preparation
    • Accurate and timely data entry (EDC)
    • Prepare for monitor visits
    • Perform vitals, EKG’s and other study procedures as directed by Study Coordinator
    • Conduct Quality Assurance / Quality Control review of patient data
  • Keep all study lab kits organized and in stock
  • Organize and track study storage for archived studies

Previous medical office, research, or hospital experience desirable.

Training and evidence of competencies are reviewed by a supervisor to determine RA level.

High School Diploma required.

An associate’s degree in medical assisting or experience as a nursing assistant is preferred.

Position Summary

Performs study visits under the direction of PI and study coordinator. Provides support to RCR team as needed and delegated.

Essential Job Functions

  • Facilitate visits per protocol at the direction of the PI
    • Follow the research protocol directly
    • Adhere to good clinical practices
    • Responsible for ongoing, active communication of study progress, questions, issues with Investigator and sub-investigator
  • Ensure study source documents for assigned trials reflect all necessary data points per protocol and data capture system, using the RCR template and process (clerical assistance) including inclusion/exclusion and appropriate involvement of PI and in conjunction with QA director template and review.
  • Perform study visits and accurately complete study sources for any of the site’s ongoing studies once delegated and trained on the protocol.
    • Administer informed consent to subjects according to RCR’s processes
    • Review and document subject’s inclusion-exclusion criteria, ensure all criteria are met prior to Principal Investigator signing off on randomization
    • Review and document subject’s medications and indications for use
    • Perform vitals, ECG’s, phlebotomy, and other tests as delegated and needed (site support staff available)
    • Collect and report Adverse Events
    • Follow protocol
    • Adhere to good clinical practice
  • Complete study sources for any of the site’s ongoing studies once delegated and trained on protocol

Strong clinical background with evidence of independent clinical assessment skills and strong attention to detail preferred.

A minimum of a 4-year degree in the science field is required.

  • Regulatory Document Processing – Paper and eRegulatory Systems
  • Responsible for the completion, submission, and tracking of all regulatory documents for all protocols as required including but not limited to: 1572, Protocol and Investigator’s Brochure Signature Pages, Financial Disclosure Forms, Initial Delegation Log, IND Safety Reports, Data Archives, Training Logs
  • Responsible for updating applicable forms with staff changes
  • Ensure tracking and processing of all updated regulatory items namely Protocols, Consents, and Investigator’s Brochures. Sets up training logs for updated documents appropriately.
  • Responsible for the completion, submission, printing, processing and tracking of all IRB documents for all protocols including but not limited to: Initial IRB submission forms, IRB SAE submissions, IRB Deviation submissions work with Quality for IRB deviations for CAPA wording, Continuing Reviews, Informed Consent site change requests, IND submissions (if not done centrally), site information changes (goal increase/FDA audits), and Closeout Reports.
  • Responsible for updating applicable forms with staff changes
  • Responsible for distributing IRB Rosters as they are update
  • Electronic study folder set up and archiving of all above listed documents, including moving files from potential studies to Study Folders drive and eRegulatory Systems
  • Ensure Clinical Trial Management System has accurate and complete protocol information (Protocol, description, sponsor, contacts)
  • Set up for new studies: create binders and logs, memos to file, Set up of initial Study File Notebooks for all studies in applicable regulatory systems
  • Maintain central files
  • DEA licensure and registration, Controlled Substance Licensure, GDUFA, FWA, and other central licenses/certifications such as CCRC
  • Create Staff CVs and Medical Licenses
  • Annual CV Update- auditing of staff participation on studies and updating CVs accordingly
  • Set up of Study Flashdrive as needed or by request and audit at end of study for all necessary documents
  • Support PI in maintenance of all staff and study profiles in SIP accounts
  • Support new staff onboarding with creation of pertinent accounts
  • Support management and regulatory documentation related to satellite or partner sites
  • Assist Study Coordinators and Sponsor monitors with regulatory issues, escalate issues to Administrative team as needed
  • Assist in preparation for Sponsor and FDA audits
  • Assist Director of Business Operations by printing finalized CTA’s/budgets, obtaining appropriate signatures, submitting via mail or electronically to the necessary contacts and saving in the electronic study files. Ensure copy is given to payroll for input. Ensure fully executed version is obtained. Update CTMS system with status

Job Description:

  • Assist with the development and maintenance of accounting systems for financial transactions
  • Maintaining the general ledger, recording cash receipts and financial transactions
  • Reconciling bank, credit card accounts and intercompany accounts
  • Coordinate collection activities, with support from the team, including calls and emails to customers, and internal escalations as required for problem accounts
  • Generate and send stipends to volunteers
  • Streamlining AR functions by maintaining/coding applicable customer discounts and supporting communication on discrepancies
  • Month-end close procedures
  • Maintaining on-time and proper customer invoicing
  • Ensure that receivables are collected promptly
  • Prepare accounts receivable/payable reports, analyzing the data and recognizing the trends
  • Provide accounting and financial support to management as needed
  • Positive contributor to the team by supporting and executing projects as needed
  • Other ad hoc projects as assigned
  • Prepare, support and response related to freight claims
  • Monitoring company accounts and conducting quarterly reviews
  • Accounts payable
  • Accounts receivable
  • Profit-and-loss statements
  • Expense reports
  • Payroll

Experience:

  • Accounting: 2 years (required)
  • Quickbooks: 1 year (required)

Job type: Full-time