Clinical Research Coordinator at Oncology Consultants P A

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

0.0

Posted On

25 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Protocol Feasibility, Regulatory Submissions, IRB Documentation, Subject Recruitment, Eligibility Evaluation, Source Document Review, Informed Consent, Drug Accountability, Venipuncture, Specimen Processing, Data Abstraction, Data Query Resolution, Sponsor Monitoring, Case Report Forms, FDA Inspections

Industry

Hospitals and Health Care

Description

Description The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. The Clinical Research Coordinator is involved in multiple aspects of the research process under the general supervision of the Research Department Administrator. Requirements ESSENTIAL DUTIES AND 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 Additional Duties and Responsibilities: 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. Education and/or Experience: 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 LANGUAGE SKILLS: • Strong Verbal and written communication skills • Proficient in written and verbal English • Bilingual is a plus COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

Responsibilities

The Clinical Research Coordinator manages various aspects of clinical trial execution, including patient recruitment, ensuring protocol compliance, managing study drugs and specimens, and maintaining accurate documentation.