Job description

Reports To: Clinical Research Manager

We want you on our team! The Center for Cancer and Blood Disorders has more than 50 cancer specialists and 250 healthcare professionals representing many different areas of medical and administrative services across 16 locations throughout North Texas. We can offer you a competitive salary and a complete benefits package. The Clinical Research Coordinator works coordinate various aspects of care for patients enrolled in research trials, manages the distribution and collection of essential data required to complete assigned research projects, and assures that all data is collected in compliance with FDA and GCP/ICH standards. The successful Clinical Research Coordinator will be able to work in a fast-paced environment bringing with them self-motivation, critical thinking skills, excellent verbal and written communication, and a meticulous organization/attention to detail.

Major Job Responsibilities for Clinical Research Coordinator:

• Maintains highest level of confidentiality at all times
• Adheres to clinic and research policies and procedures
• Demonstrates business practices and personal actions that are ethical and adhere to corporate compliance and integrity guidelines
• Serves as a liaison for clinical staff for issues related to clinical trial management
• Serves as a point of contact for the sponsor and other entities involved in clinical research studies, promoting a proactive and professional relationship with external affiliates regarding clinical research.
• Assists with processing contracts, agreements, and work orders for approval in accordance with DCH contract management guidelines and facilitates grant management with the accounting department, under the direction of the Clinical Research Manager
• Assists with collecting internal quality data, generates reports, and presents performance data reports and discusses findings at appropriate forum
• Develops goals annually to address the specific departmental needs
• Attends and participates in meetings that may require travel
• Attends and participates in department and hospital meetings as required
• Assists with distribution of study information to appropriate parties
• Receives training and maintains competency with sponsor's electronic data capture systems as needed
• Verifies study eligibility and study enrollment requirements with source documents
• Obtains consent/assent for research participation in accordance with applicable federal, state, and local regulations and institutional policies/procedures
• Ascertains that data collected by staff are complete and verifiable from source documents
• Assists with preparation of source document templates in accordance with the protocol, case report forms, and electronic data capture systems.
• Collaborates with clinical staff and ancillary departments for protocol training and scheduling and care for enrolled subjects
• Collects and submits study data within sponsor-required timelines
• Coordinates with laboratory personnel to collect and ship specimens to study central laboratories in accordance with protocol requirements
• Assist with patient scheduling as needed, coordinating appointments with other providers associated with protocol care (i.e. cardiology, x-ray, scans) as well as facilitating coordination with other departments of our practice and/or hospitals associated with providing service to research patients
• Participates in site selection visits, study initiation visits, and monitoring or inspection visits, including facility tours, source document compilation and verification.
• Maintains research charts for study participants in accordance with DCH guidelines.
• Ensures compliance with protocol related treatments and evaluations by maintaining a quality assurance process and assisting the PI and Clinical Research Manager with designing and implementing process improvement as needed
• When needed, assists in the preparation of documents for Institutional Review Board submission including informed consent, protocol amendments and safety reports
• Assists with development of department SOPs; provides suggestions for improvement
• Practices and promotes cost-effective use of resources and makes recommendations for improvement
• Promotes exceptional customer service and support of the plan of care per protocol
• Self-directed in developing their own performance in relation to professional standards and relevant statues and regulations
• Performs other duties as necessary

Typical Physical Demands for Clinical Research Coordinator:

Work may require long periods of sitting; also stooping, bending and stretching. Occasionally, lifting files or paper weighing up to 50 pounds is required. Manual dexterity sufficient to operate a keyboard, calculator, telephone, copier and other equipment is also necessary. Vision must be correctable to 20/20 and hearing must be in normal range for telephone encounters. The ability to work under stressful or emergency situations with high concentration and energy level is also required.

Typical Working Conditions:Work is performed in a clinic/office environment and involves contact with patients and public alike. Work under occasional pressures due to multiple studies, patients, and data deadlines is common; as well is the ability to diplomatically interface with physicians, clients, and coworkers.

Travel: Will require some commuting between clinics to meet needs of studies (Fort Worth, Burleson, Arlington, Weatherford).

Minimum Job Requirements for Clinical Research Coordinator:

• Experience working as a clinical coordinator or healthcare professional in a clinical setting (oncology preferred).
• Knowledge of current FDA regulations, and Good Clinical Practices (GCP’s), governing clinical research.
• Understanding of ethical & legal liability, and patient safety issues associated with non-compliance with regulations governing research.
• Must have professional demeanor and strong communication skills with the public as well as physicians/researchers.
• Knowledge of medical terminology.
• Proficiency in Microsoft Office and Google Workspace.
• Detail oriented, precise, and accurate

Education:

• Degree in a science discipline from a college or university with a 4-year bachelor’s preferred; OR one to two years related experience and/or training; or equivalent combination of education and experience in conducting clinical trials
• Research experience with knowledge of the conduct of clinical trials preferred but not required
• Hematology/Oncology experience is preferred but not required

Applicable Certificate/licenses:

• Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification required following 2 years of employment
• Current professional nurse licensure in the state of Texas if applying with a nursing background

This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Work Location: In person

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