Research Coordinator
Research Coordinator
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Clinical research study point of contact and accountable for coordination of each assigned trial from beginning to the end under the direction of the Principal Investigator Subinvestigator and Clinical Trial Management in adherence to the FDA ICHGCP IRB HIPAA RCCA SOPs US Oncology Compliance Program RCCA Code of Ethics and Business Standards.
Employment Type: Full Time
Location: Riverdale NJ
As of the date of this posting RCCA offers a comprehensive benefits package for this position subject to eligibility requirements. In addition to the salary we provide: Health dental and vision plans Wellness program Health savings account Flexible spending accounts 401(k) retirement plan Life insurance Shortterm disability insurance Longterm disability insurance Employee Assistance Program (EAP) Paid Time Off (PTO) and holiday pay Tuition discounts with numerous universities Employeepaid critical illness and accident insurance.
We believe these benefits underscore our commitment to the wellbeing and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Demonstrate understanding of the protocol elements and requirements.
- Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
- Perform studyspecific procedures and tasks under the supervision of the PI SubI and Clinical Trial Management with high quality.
- Screening recruit enroll prospective patients using EMR EDC CTMS
- Create and maintain enrollment logs for each trial from beginning to end
- Schedule and follow up patient visits (clinician infusion nurse room imaging EKG and all necessary tests ordered by the PI or SubI) and obtain patient results required for assigned trial.
- Collaborates with the cross functional team (RCCA front desk precert team practice administrator pharmacy tech pharmacist radiologist nurse practitioner registration nurse phlebotomist medical assistances clinicians PI SubI clinical management team HQ) involved in the trial.
- Oversee study kits study drug accountability records study kits/IMP drug destruction and maintenance.
- Enter all the data to EDC and EMR within 24 hours of data collection.
- Communicate and resolve all the data queries within 5days
- Understand monitor and report patient safety adverse events serious adverse events and protocol deviation within 24 hours of occurrence to PI SubI Clinical Trial Management and Regulatory Coordinator.
- Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs 1572 Investigational Brochure Signature Protocol Signature Page GCP certificates medical license IATA training records DOA logs CLIA certificates radiology agreements calibration records EKG 20 refrigerator 80 drug ice storage for the specimens temperature logs and other required essential documents
- Ensure compliance with RCCA SOP US Oncology Policies HIPAA IRB FDA and ICHGCP guidelines at all times.
- Provide timely and complete updates to study team members regarding changes to workflow or patientrelated specific needs by the protocol or SOP
- Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
- Interacts with Research Sponsors site personnel IRBs (Institutional Review Boards) and other research entities regarding Regulatory and research studyrelated issues.
- Supports internal and external audits
- Ability to take initiative to resolve protocolrelated concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
- Centrifuge process prepare ship and store biological materials by the sponsor protocols RCCA SOP IATA and universal biohazard precautions.
- Conduct clinical trial weekly and monthly meetings within the division.
- Require attending SIV RMV IMV COV and assigned trial adhoc meetings.
- Track and submit clinical trial patient reimbursement.
- Other duties as assigned.
- Minimum 1 year of experience with oncology interventional clinical trials.
- ACRP (CCRC CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience.
- High School diploma with four years of oncology clinical trial experience
- Computer literate with good interpersonal writing and verbal communication skills
- Previous regulatory affairs experience is a plus.
- Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm all RCCA network
- Prior experience working with centrifuge and handling biofluid specimens is preferred.
- Ability to multitask and prioritize in a fastpaced work environment time management skills and ability to work well under pressure.
Required Experience:
IC
Employment Type
Full-Time
