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...
JOB PURPOSE
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 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.
ADMINISTRATIVE DUTIES
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
SUPERVISION RECEIVED
Clinical Research Coordinator is supervised by Principal Investigator
SUPERVISION EXERCISED
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
DIRECT REPORTS
Clinical Research Coordinator reports to Principal Investigator
MI EXPERIENCE REQUIREMENTS
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.
PREFERRED EXPERIENCE REQUIREMENTS
Oncology Research Experience
PREFERRED EDUCATION REQUIREMENTS
Clinical Research Coordinator
Registered Nurse with Oncology experience
Human Subject Training Certification
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