Oncology Consultants · 22 hours ago
Clinical Research Coordinator
Houston,TX,US
Full-time
Onsite
Entry, Mid LevelOncology Consultants is involved in clinical trial management and is seeking a Clinical Research Coordinator to join their Research Team. The role includes evaluating protocol feasibility, assisting in regulatory submissions, participating in subject recruitment, and ensuring compliance with study protocols.
Health CareMedicalOncology
Responsibilities
Consistently exhibits behavior and communication skills that demonstrate commitment to superior customer service, including quality, care and concern with each and every internal and external customer
Applies knowledge of study design to evaluate protocol feasibility at the site
Assists Regulatory staff in preparing and submitting documents to institutional review board
Participate in study site initiation activity
Attends and participates in investigator meetings and clinical trial conferences as directed
Participates in subject/patient recruitment and evaluation of eligibility
Reviews and verifies required source documents in subject’s medical record to confirm study eligibility
Reviews inclusion/exclusion criteria with investigator to assure subject eligibility
Conducts interviews to assess the subject’s ability and willingness to follow and complete study procedures and visits
Maintains patient screening enrollment logs
Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects
Follows randomization procedures per protocol
Ensures that study drugs are dispensed as per protocol by the study team or research pharmacy and that all study drug accountability records are maintained
Reviews returned drugs for compliance and documents findings
Direct care in study compliance throughout the research experience and may include
Peripheral Venipuncture per OC standard
Ensures appropriate specimen collection, batching and shipping as required
Work collaboratively with the site staff to appropriately process the specimens
Prepare and ship the study required specimen, per protocol manual
Obtain results and report to the attending physician investigator
Attend all clinic visits with the attending physician investigator and assist in following the study guidelines
Documents protocol deviations and exemptions
Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results)
Abstracts data from medical records, clinic, consultation and referral notes to study forms and flow sheets
Resolves data queries
Schedules sponsor monitoring
Prepares case report forms and collects source documents for sponsor / audit review
Prepares for and participates in FDA inspections
Communicates effectively with subjects, research team, IRB’s and sponsors
Participates in educational and training activities
Attends continuing education offerings
Supports and assists management team with department projects
Assist in maintenance of budgetary data for each clinical trial
Assist in planning department coverage (patient clinic visits, data management, meetings)
Qualification
Required
Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), other
Continuing education participation is expected, and research certification through a recognized national organization is encouraged. (SOCRA, ACRP)
NIH protection of Human subjects on line course will be required annually
IATA training will be required every 2 years
Strong Verbal and written communication skills
Proficient in written and verbal English
Preferred
Bilingual is a plus
Company
Oncology Consultants
Oncology Consultants has been a premier adult medical oncology and hematology practice in Houston, TX for over 25 years.
Founded in 1999
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Rosa Fletcher
Chief Executive Officer
Recent News
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