Clinical Research Coordinator III – DIRECT HIRE
Mckinney, TX, US
Scientific
Unspecified
Full Time, Direct Hire
$60-75,000/Year (commensurate with experience)
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Mckinney, TX, US
$60-75,000/Year (commensurate with experience)
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Unspecified
First Shift (Day)
Job details
Senior Clinical Research Coordinator
Kelly® Science & Clinical is seeking a Clinical Research Coordinator III for a direct hire position at a leading client in McKinney, TX. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate:
$60-75,000/Year (commensurate with experience)
Overview:
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.
Responsibilities:
- 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.
Qualifications:
Essential Qualifications:
- Minimum 2-3+ years Clinical Research Coordinator experience.
- Vitals, ECGs, phlebotomy, sample processing and shipping experience.
- IV placement is a plus.
- Endocrinology experience preferred.
- Self-motivated, team player with strong attention to detail and ability to multitask.
- GCP Certified.
Required Skills/Abilities:
- Experience leading 6-8 studies preferred.
- Ability to work independently and as a member of a team.
Education & 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.
What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.
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Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.