Clinical Research Coordinator

Company: KP Recruiting Group
Location: Philadelphia
Posted on: May 28, 2023

Job Description:

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world's leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

The Role:

The Clinical Research Coordinator will support such researchers providing the required elements necessary to retain regulatory and ethical compliance with all aspects of the clinical trial process. Responsibilities include the following but are not limited to:

Skills & Abilities:
--- Conducts full clinical research coordinator duties for assigned trials
--- Ability to manage and serve as coordinator for 10-15 clinical research studies
--- Promptly documents and reports any observed protocol/trial issues to the IRB, OR, and PI
--- Ensure established procedures are utilized in reviewing the collection of clinical data and the administration of clinical trials.
--- Assist new researchers with development, planning, and execution of their research.
--- Prepares and submits IRB documents under the direction of the PI and prepares regulatory documents to be sent to the Sponsor; assists in addressing documents and contracts through IRB process and approval; under direction of PI may draft various communications with Sponsor.
--- Ensure compliance the Human Subject's Protection Program when submitting IRB applications.
--- Dissects protocol for budget cost analysis, in collaboration with the Office of Research Support
--- Assists in the submission of new confidentiality agreements in a timely manner
--- Assists in the submission of new study protocols, /budgets and facilitates timely initiation of the contract
--- Coordinates and participates in the pre-site and site initiation visits.
--- Coordinates study initiation and assists with planning and design of source documents for protocol; adhering to study protocol
--- Conducts ongoing recruitment of volunteer subjects for clinical research; screens subjects for protocol eligibility and participation; and monitors enrollment goals.
--- Organizes and facilitates assisting PI in obtaining Informed Consent from study participant and documents appropriately.
--- Assists with accurate source documentation and appropriate forms as per protocol on all participant records, drug accountability, test devices and clinical supplies.
--- Utilizes data resources external to research area, as well as develops and facilitates productive working relationship with the study monitor.
--- Works in collaboration with the Office of Research Support to ensure that all research patients are identified, tagged and billed appropriately
--- IATA certified to process and ship human specimens
--- Remain 100% audit ready
--- Order supplies necessary to conduct research.

Other:
--- Resource Management:
--- Demonstrates the ability to plan effectively by recognizing and setting priorities, and completing assignments in a timely manner.
--- Organizes work effectively, adjusts well to changes in work schedule, work flow, and priorities.
--- Seeks to utilize equipment, time, supplies, phones and other clinical research resources properly and efficiently
--- Quality and Teamwork:
--- Operates in a collaborative manner, and is open and flexible to the ideas of others.
--- Seeks to provide the highest quality service in an accurate, thorough, and timely manner
--- Communication: Communicates (verbally and in writing) clearly, accurately and effectively.
--- Initiative: Volunteers assistance to others, seeks additional assignments when work is completed, is flexible and willingly accepts additional responsibilities.
--- Initiative: Makes all reasonable attempts to solve problems independently before turning them over to the supervisor.
--- Judgment/Decision Making: Exhibits sound judgment and makes appropriate decisions in a timely manner

Requirements
--- A minimum of 3 years of experience working in a clinical research environment; 5 years preferred.
--- Sound knowledge of Good Clinical practices
--- Sound knowledge of FDA regulations
--- Good organization skills are essential
--- Microsoft Office suite knowledge

Benefits

• 401k Matching
• Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
• Paid Time Off & Paid Holidays
• Long & Short-Term Disability
• Identity Theft Plans
• Retirement & Pension Plans
• Employee Assistance Program
• Employee Referral Program
• Tuition Reimbursement Programs
• Advancement & Professional Growth opportunities
• Parental Leave
• & More

Keywords: KP Recruiting Group, Philadelphia , Clinical Research Coordinator, Healthcare , Philadelphia, Pennsylvania