Clinical Research Coordinator
Minimum 8-10 years of experience in a clinical or scientific related discipline required, preferably in Oncology...
Clinical Research Coordinator
The Clinical Research Coordinator plays a key role in presenting treatment alternatives...

The Clinical Research Coordinator plays a key role in presenting treatment alternatives and an assessment of treatment risks and benefits associated with each clinical trial. The Clinical Research Coordinator primary role is to ensure completeness, accuracy, and compliance with each protocol and to assist principal investigators and co- investigators of clinical studies in coordinating and facilitating the activities of participants in clinical research protocols. He/she is also responsible for identifying clinically significant events through patient assessments and review of a variety of medical documents (e.g., medical records, laboratory reports). The CRC Nurse is responsible for following institutional standards of Research Nursing Practice within his/her scope of duties and responsibilities.

  • Duties include the collection and organization of patient data in electronic format utilizing proprietary EDC system (FICS), responding to sponsor queries, identifying, reporting and following up on Serious Safety Events, performing limited number of procedures with study subjects, telephone follow-up with survivors, clarification of protocol questions, obtaining consent, gathering lab, op, pathology reports, and radiology reports and tissue specimens from referring hospitals, completing case reports forms, preparing for audits by sponsors, ECs and/or Health Authorities
  • Read and understand Clinical Trial Protocols to identify high-fidelity patient matches for various cancer types in both oncology and hematology.
  • Evaluate patients against specific genetic and clinical inclusion and exclusion criteria in FICS.
  • Work with multiple data sources, including EMR databases and paper records, to extract relevant information and input into FICS workflow.
  • Assists with coordinating the implementation and conduct of research projects ensuring adherence to research protocol requirements including timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reports Serious Adverse Events as they occur and completion and sponsor forms in accordance with GCP guidelines.
  • Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment, and safety questions.
  • Utilizes the nursing process as a basis for patient care.
  • Assesses research subject; completes nursing assessment, documenting findings in research subject records. Notifies physician of abnormal findings, assists in AE/SAE causality assessments, completes concomitant records, Oncology meds, and Oncology procedures and reconciles with relevant medical history and AEs.
  • Familiarity with RECIST criteria for data entry purposes.
  • Establishes a care plan in collaboration with the research subject, family, and research team.
  • Performs telephone triage.
  • Performs nursing procedures and treatments as directed by Physician in the treatment and management of patient care.
  • Evaluates, initiates, and maintains standards of care consistent with CCRI/local policies & procedures.
  • Assists with specialized patient care equipment as required by the clinical research protocol.
  • Administers medications and treatments as ordered by a physician.
  • Documents the education and training of research personnel as needed (Study logs in FICS).
  • Assists with the development and completion of protocol specific checklists.
  • Assists in educating the patient/family and team on the research protocol.
  • Conducts and documents the informed consent process.
  • May assist with research project budget development.
  • Identifies, assesses eligibility, enrolls, and collects accurate medical and demographic history on research subjects for a variety of studies.
  • Responsible for scheduling of patients in clinical care and trial subjects in FICS
  • Provides direct clinical services to subjects; observes subjects and notifies clinicians of any medical/emotional change
  • Contributes to protocol development, submission, and renewal by collecting written materials and writing procedural documents; ensures ongoing compliance with Ethics Committees (ECs) policies by monitoring changes in EC policies related to human specimens and informing the research team of such changes
  • Reviews, codes and contributes to the entering of all collected patient data to assure completeness and accuracy.
  • Utilizes clinical knowledge and assessment skills necessary to evaluate, report and record accurate medical information, including responses to therapy. Responsible for maintaining the drug accountability records in FICS in conjunction with Pharmacy.
  • Promotes research study initiation and review in FICS by completing site level milestones, site qualification requirements, site initiation requirements, study log completion, and eISF configuration.
  • Acts as the project representative and professional resource for coordination of staff, sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. Reads and evaluates clinical research protocols.
  • Attends departmental, committee, and sponsor meetings for the purpose of gathering new or revised information concerning existing or potential clinical research projects.
  • Assists in the development and maintenance of budget and/or contract agreements. Follows policy requirements for reporting patient enrollment, FICS CTMS forms completion, and eCRF completion to ensure compliance with billing. Assists in the development of accounting reports for billing purposes.
  • Coordinates and safely implements research activities through interactions with research staff, internal and external investigators, study sponsors and Ethics Committees.
  • Schedule all protocol required evaluations (physical exams, radiology, labs, etc. and coordinate patient appointments with physicians, nurses, and all test areas.
  • Coordinate, obtain, process (e.g., spin/separate/freeze samples), and ship (e.g., utilization of specific packaging and ensuring proper handling and shipping of samples) protocol required samples.
  • Develop/Maintains protocol specific flow charts in FICS, intake sheets and other tools as needed to ensure protocol compliance and proper data acquisition, in addition maintain study supplies and utilizes study specific supplies as required.
  • Assists the Principal Investigator in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan and maintains documentation of training.
  • Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and GCP.
  • Coordinates and facilitates monitoring and auditing visits and notifies appropriate institutional officials of external audits by FDA and sponsors.
  • Collaborates with Principal Investigator and institution to respond to any audit findings and implement approved recommendations.
  • Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated.
  • Serve as facilitator for study team and sponsor regarding study status information, safety issues, upcoming protocol amendments and consent changes and applicable protocol training.
  • Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IEC review and approval.
  • Prepares and submits regulatory documentation that may include IND/IDE applications, CDSCO annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies
  • Clinical Research Coordinator is supervised by Principal Investigator
  • CRC ensures that the clinical research staff are appropriately trained and adhere to the clinical trial schedule, which may include maintaining, dispensing, and recording drug and supplies according to regulations.
  • CRC ensures that clinical research staff conduct the clinical aspects of the projects appropriately and adhere to the schedule of the clinical trials, serving as an advocate for the research participant, assisting them through the research process
  • Clinical Research Coordinator reports to Principal Investigator
  • Minimum 8-10 years of experience in a clinical or scientific related discipline required, preferably in Oncology.
  • Experience in Microsoft Office
  • Must have excellent communication skills.
  • Excellent organizational skills
  • Strong ability to multi-task
  • Excellent time management skills
  • Must have strong interpersonal skills to be able to interact with multiple people on many different levels.
  • Must have a high level of attention to detail.
  • Must be able to work in a fast-paced environment.
  • A large percentage of time performing computer-based work is required.
  • Oncology Research Experience
  • Clinical Research Coordinator
  • Registered Nurse with Oncology experience
  • Human Subject Training Certification

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