Research Coordinator
Research Coordinator
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Job Description
Are you ready to be a pivotal force in groundbreaking cancer research RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
Were seeking someone with a knack for multitasking a positive outlook and an undeniable passion for making a difference. If youre eager to join a team thats leading the charge in cutting-edge cancer care and places the patient at the forefront we want to hear from you!
Employment Type: Full Time
Location: Sparta NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills experience and qualifications
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 Short-term disability insurance Long-term disability insurance Employee Assistance Program (EAP) Paid Time Off (PTO) and holiday pay Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being 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 study-specific procedures and tasks under the supervision of the PI Sub-I 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 Sub-I) and obtain patient results required for assigned trial.
- Collaborates with the cross functional team (RCCA front desk pre-cert team practice administrator pharmacy tech pharmacist radiologist nurse practitioner registration nurse phlebotomist medical assistances clinicians PI Sub-I 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 5-days
- Understand monitor and report patient safety adverse events serious adverse events and protocol deviation within 24 hours of occurrence to PI Sub-I 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 ICH-GCP guidelines at all times.
- Provide timely and complete updates to study team members regarding changes to workflow or patient-related 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 study-related issues.
- Supports internal and external audits
- Ability to take initiative to resolve protocol-related 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 ad-hoc meetings.
- Track and submit clinical trial patient reimbursement.
- Other duties as assigned.
Minimum Job Qualifications:
- 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 in all RCCA network.
- Prior experience working with centrifuge and handling biofluid specimens is preferred.
- Ability to multi-task and prioritize in a fast-paced work environment time management skills and ability to work well under pressure.
Working Conditions:
- Traditional office environment
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases toxic substances ionizing radiation medical preparations and other conditions common to an oncology/hematology clinic environment.
- Physical Requirements (Lifting standing etc.)
- Large percent of time performing computer based work is required
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Required Experience:
IC
Employment Type
Full-Time
