Sr. Clinical Research Coordinator - Site Lead Job at MyKelly, Irving, TX

TURGeDE5VjdPcFdGeCtMZFNnMkF0SFlIK0E9PQ==
  • MyKelly
  • Irving, TX

Job Description

Kelly Science & Clinical® is working with a Clinical Research Site Network with an immediate need for an experienced Clinical Research Coordinator with site leadership experience for the Dallas Metro area.

Position: Clinical Research Coordinator III (Full-Time/Non-Exempt): On-Site

Responsible for the overall management the studies assigned to you including administrative duties, such as regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager. Adherence to site SOPs is required.

Reports to: Site Lead/Manager

Job Description:


The Clinical Research Coordinator (CRC III) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC III to communicate with the investigator, sponsor and study participants all necessary information of the study. It is the responsibility of the CRC III to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.
  • Inform study participants or caregivers about study procedures and outcomes to be expected
  • Train study team members and 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 study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
  • Have all source documentation completed, entered into EDC within 48 hours of study participants visit
  • Inventory lab and study supplies. Order supplies or delegate to Research
  • Assistant to order needed supplies
  • Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
  • 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 study participants, 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
  • Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
  • 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 study participants in appropriate medication log
  • Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment)
  • Prepare for or participate in quality assurance audits
  • 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 as needed
  • Prepare study participants source documents prior to patient visit
  • Maintain training logs on all up-to-date studies
  • Maintain and update study delegation logs
  • 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
  • Functions as a subject matter expert in the area of Clinical Research to provide support and guidance for peers
  • Other duties as assigned

Required Skills/Abilities:

  • Experience leading 6-8 studies preferred
  • Ability to work independently and as a member of a team

Education and Experience:

  • GED or HS Diploma required (Some College preferred)
  • 5+ years clinical research experience required

Physical Requirements:

  • Must be able to work remotely and be available during business hours
  • Must be able to lift up to 15 pounds at times
9539403

Job Tags

Full time, Local area, Immediate start,

Similar Jobs

ICON

Clinical Research Nurse I Job at ICON

 ...Clinical Research Nurse I - Full Time/Permanent- ICON San Antonio TX ICON plc is a world-leading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us... 

InfoLabs

Civil Construction Project Manager Job at InfoLabs

 ...Job Description Job Description Civil Construction Project Manager Location : Liberty, TX Duration : 6-12 Months (Contract to Hire) Job Summary : The Civil Construction Project Manager will be responsible for managing large-scale construction projects... 

RaiZan Solutions

CNC Operator Job at RaiZan Solutions

 ...Job Description Job Description CNC Operator (Urgent Hire) Location: Stevensville, MI Raizan Solutions LLC is hiring for their client as a direct hire. Raizan Solutions does not charge candidates. Must-Haves: Minimum 5 years of experience as a CNC Operator... 

DLZP Group, LLC

PeopleSoft ERP Systems Administrator Job at DLZP Group, LLC

 ...Job Description Job Description We are looking for skilled technical PeopleSoft Systems Administrator. Candidate will be primarily responsible for maintaining the secure computing environment by identifying PeopleSoft system requirements, installing upgrades and monitoring... 

Cadogan Tate

Human Resources Administrative Assistant Job at Cadogan Tate

 ...Description Job Description Description The purpose of this role is to provide support the HR Manager. As part of the human resources team, HR Assistants ensure that workplace needs are being met in the form of benefit administration, salary determination and employee...