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Rivus Wellness and Research Institute
Oklahoma, OK | Full Time
$47k-63k (estimate)
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Clinical Research Coordinator
$47k-63k (estimate)
Full Time 11 Months Ago
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Rivus Wellness and Research Institute is Hiring a Clinical Research Coordinator Near Oklahoma, OK

Rivus Wellness and Research Institute is growing and we are looking for individuals who are passionate about delivering exceptional patient care. In this position, you will be responsible for the overall management of your assigned studies including both patient care and administrative duties. The ideal candidate for this position will be self-driven perfectionist and able to prioritize and complete multiple tasks in a timely and efficient manner. This position is responsible clear and direct communication with the study sponsor, study monitor, CRO, principal investor, and site director. Adherence to site SOP's and sponsor protocols is expected and required.
Previous experience as a clinical research coordinator with a track record of success is required.
Essential Duties
  • Inform patients or caregivers about study procedures and outcomes to be expected. 
  • Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. 
  • Have all source documentation filled out and completed while the patient visit is occurring and while the patient is on site for optimal accuracy of data collection. 
  • Reschedule study patients on the research calendar within the window specified per protocol. 
  • Have all source documentation completed, entered into EDC, flagged for PI signature and sent to Quality Assurance within 48 hours of patient visit. 
  • Track enrollment status of subjects and document dropout information such as dropout cases and subject contact efforts. Contact efforts should be documented in source documents if lost to follow up. 
  • Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies. All supplies should maintain with an abundance of lab kits in order to fulfill all needed visits. 
  • Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting. Completes required protocol, EDC and any additional training while at meetings. 
  • Attend site initiation visits from various drug sponsors and conduct site initiation tours. 
  • Confer with business/recruitment department to determine the best recruitment practices for studies. 
  • Maintain required records of study activity including case report forms, drug dispensation records. 
  • Communicate with laboratories or investigators regarding laboratory findings. 
  • Order drugs or devices necessary for study completion. 
  • Direct the requisition, collection, labeling, storage, or shipment of specimens. 
  • Perform specific protocol procedures such as interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens. 
  • Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors. 
  • Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits to answer questions about issues such as incomplete data and data query resolution and be the point of contact for the monitor while on site for monitoring visits. 
  • Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor. 
  • Have all queries resolved in EDC and in source documentation by the end of each monitoring visit. 
  • Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary. 
  • Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to subjects in appropriate medication log. 
  • Initiate and maintain accurate master log for each study. Master log includes ICF lot, patient ID log, enrollment log, and medication log. This log should be kept with coordinator and provided to monitor at each monitoring visit. 
  • Prepare for or participate in quality assurance audits conducted by study sponsors and federal agencies. 
  • Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug logs. 
  • Maintain accurate temperature logs daily for drug room, -20 degrees in freezer and refrigerator in lab. 
  • Receive study newsletters, lab, EKG and scale over reads from fax- stamp received, have coordinator review, initial and date. Flag for PI to sign and file in appropriate patient chart. 
  • Copy all EKG thermal paper after PI has signed it and file behind original EKG paper in chart. 
  • Clean exam room after study patient use. 
  • Prepare patient source documents and binder including scales and appropriate study specific documents prior to patient visit. Headers and date should be profiled. If screening visit or revised consent was issued include appropriate consent in binder pocket. 
  • Prep lab tubes and labels before each study visit. 
  • Check crash cart drug supplies for expiration monthly. 
  • Submit initial regulatory packet and paperwork when awarded a new study within a timely manner. 
  • Maintain training logs on all up to date studies. 
  • Maintain financial disclosure forms. 
  • Maintain 1572's.
  • Maintain and update study delegation logs. 
  • IRB communication submission. 
  • Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner. 
  • Inform coordinators and research assistant of informed consent and protocol amendments and provides a copy to coordinator and PI and dispose of all old copies on site.
Requirements
  • Previous clinical research coordinator experience (1 years) 
  • Highschool Diploma or equivalent
  • Ability to multitask 
  • Ability to follow site SOP and sponsor protocols without deviation
  • Strong verbal and written communication skills 
  • Ability to work on multiple computer platforms for patient record keeping 
  • Ability to meet and exceed goals
  • Ability to travel if/when in person investigator meetings resume
Additional Info
  • Monday-Friday 8am-5pm 
  • Full BENEFITS after 90 days!! 
  • FULL TIME. 40 Hrs/week
  • 2 weeks PTO 

Job Summary

JOB TYPE

Full Time

SALARY

$47k-63k (estimate)

POST DATE

06/05/2022

EXPIRATION DATE

05/24/2024

WEBSITE

rivusinstitute.com

HEADQUARTERS

Oklahoma City, OK

SIZE

<25

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