Prescreening Clinical Research Coordinator

Socket.dev; Dallas (TX); On-site; USD 58,000 - 78,000; Full time

Job summary

Texas Oncology is seeking a Clinical Research Coordinator to support the Dallas Region in the Oncology Clinical Research department. Typical hours are Mon-Fri, 8:30am-5:00pm.

The role spans level 1 to Sr based on candidate experience, with responsibilities spanning patient screening, consent, and study coordination within an oncology setting. The position emphasizes protocol compliance, data collection, regulatory documentation, and collaboration with physicians and sponsors in a fast-paced

Qualifications

• Associate's degree in a clinical or scientific related discipline required.
• Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology required.

Responsibilities

• Screens potential patients for protocol eligibility, presents trial concepts and details to patients, participates in informed consent, and enrolls patients in clinical trials.
• Assists with patient care in compliance with protocol requirements, may disburse investigational drug and maintain accountability, participates in data collection, entry, and reporting for subjects.
• Reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly documents all findings.
• Participates in required training and education programs as well as monitoring and auditing activities, may work with sponsors, and may schedule monitoring and auditing visits.
• Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.
• May assist in packing and shipping lab specimens; may complete Hazmat and/or IATA training.

Education

Associate's degree in a clinical or scientific related discipline

Bachelor's degree preferred

Job description

Overview

Texas Oncology is looking for a Clinical Research Coordinator to join our team!This position will support the Dallas Regionin the Oncology Clinical Research department. Typical hours for this position are Mon-Fri from 8:30am-5:00pm.

This position can be a level 1, 2 or Sr based on candidate experience

Texas Oncology is the largest community oncology provider in the country and has approximately 600+ providers in 220+ sites across Texas and southeastern Oklahoma. Our founders pioneered community-based cancer care because they believed in making the best available cancer care accessible to all communities, allowing people to fight cancer at home with the critical support of family and friends nearby. Our mission is still the same today—at Texas Oncology, we use leading-edge technology and research to deliver high-quality, high-touch, evidence-based cancer care to help our patients achieve “More breakthroughs. More victories.” ® in their fight against cancer. Today, Texas Oncology treats half of all Texans diagnosed with cancer on an annual basis.

Why work for us?

Come join our team that is responsible for helping lead Texas Oncology in treating more patient diagnosed with cancer than any other provider in Texas. We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous PTO program, a 401k plan that comes with a company match, a Wellness program that rewards you practicing a healthy lifestyle, and lots of other great perks such as Tuition Reimbursement, an Employee Assistance program and discounts on some of your favorite retailers.

What does the Clinical Research Coordinator do? (including but not limited to)

Responsible for supporting the management and coordination of tasks for multiple clinical research studies to include screening patients for eligibility and participates in the subject’s study visits and required activities per protocol. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers, and participation in required training and education, Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

Responsibilities

The essential duties and responsibilities (including but not limited to):

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.


• Assists with patient care in compliance with protocol requirements. May disburse investigational drug and maintain investigational drug accountability. Participates in data collection, entry, and reporting for the subjects.


• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.


• Participates in required training and education programs as well as monitoring and auditing activities. May work directly with sponsors. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.


• Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.


• May assist in the packing and shipping of lab specimens to central vendors. May be required to complete Hazmat and/or IATA training.

Qualifications

The ideal candidate for theClinical Research Coordinator rolewill have the following background and experience:

Level 1

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.


• Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology required.

Level 2 (in addition to level 1 requirements)

• Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.


• SoCRA or ACRP certification preferred.

Level Sr (in addition to level 1 and 2 requirements)

Minimum seven years of experience in a clinical or scientific related discipline required.

• Minimum five years of oncology and/or research experience preferred.


• SoCRA or ACRP strongly preferred.

Physical Demands

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 may be made 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.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made 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.