Eliezer Collet

Ensures all required training is completed and documented

Updates applicable tracking systems

Communicates with investigative sites

Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines

Assesses IP accountability, dispensation, and compliance at the investigative sites

Performs source document verification and query resolution

Performs essential document site file reconciliation

Escalates site and trial related issues per ICON plc SOPs until identified issues are Resolved or closed

Work closely with other clinical team members to facilitate timely resolution of trial And/or clinical issues

Completes monitoring activity documents as required by ICON plc SOPs or other contractual obligations

Provides regular site status information to team members, trial management, and

Updates trial management tools

Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

Asses the qualification of potential investigative sites, and initiates clinical trials at Investigative sites

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines

Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face-to-face interactions.

Assimilates pertinent information in order to compose written correspondence plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies

Attends appropriate departmental meetings and institutional continuing education programs

Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department

Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits

Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office applications and departmental/Institutional electronic data systems Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call.

Requires face-to face interaction with patients.

Requires ability to gather relevant information and determine the appropriate information to report.

Requires accurate and prompt patient documentation in the patient’s medical record

Consults with principal investigator (PI) and/or Mgr., Clinical Protocol Administration regarding ongoing clinical trial assignments.

Works closely with the research team to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation.

As needed, obtains patient charts and outside documents required for protocol compliance In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately Comprehends protocol and in collaboration with a Research Nurse or Mgr., Clinical Protocol Administration, develops systems for screening patients.

Assists/create source document templates and other documents as needed for protocols In consultation with the physician and/or research nurse, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols

Trains other support staff in study coordination

Schedule’s patient tests keep patients informed about test results and studies.

Collaborate with physicians, mid-level practitioners, research nurses and data managers to document patient care

Tracks protocol related labs, responses and research tests Submits information on adverse events to IRB and revises consents

Follows patients on studies and maintains knowledge of adverse events

Collaborates with physicians, mid-level practitioners, research nurses and data managers to document patient care

Under supervision of the medical staff and research nurse staff, performs protocol-specific tasks including screening, ordering tests, collecting specimens and study documentation of patient reported responses

Coordinates, evaluates and follow patient participation in clinical trials

Coordinates FDA submissions and supervises clinical trial audits Reviews patient eligibility of potential study cases and assists in obtaining consents

Collects and develops criteria information for protocol submission

Develops patient care methodology for protocols, including criteria for patient participation

Develops and maintains a processing and tracking system for all protocol related paperwork

Experience enrolling patient for therapeutic, supportive, diagnostic, non-intervention, palliative and intervention protocols Have the highest number of patients enrolled for two protocols among Houston Area Location sites Screen over 200 patients a week

Manage all study related coordination including writing, submission and maintenance of 44 protocols for all different Cancer deceases

Assist with annual reviews, updates, and response data, and generates reports as requested

Monitors informed consent files at outreach sites to assure they are up to date

Generates reports as requested

Obtains and returns charts to Medical Records when requested Requests patient charts via on-line system as necessary to facilitate research projects

Creates, prints, and distributes forms using computer and printer. Utilizes computer for word processing, spread sheets and retrieve patient data

Reviews data forms for completeness and updates as needed Enters protocol-specific data points into the appropriate database

Documents study specific information appropriately in the patient medical record

Assists in the maintenance of a system for collecting protocol data including but not limited to records of surgery, therapy dates, laboratory results, and pathology information

Assists with follow-up appointments and provides telephone reminders to patients

Obtains off-site treatment, surgery and pathology records as required

Extracts patient demographics, reports, and other pertinent information from the Medical Record Screen over 100 patients a week

Conducts structured interviews with research subjects for protocol data collection

Enrolls eligible patients under the supervision of the research nurse and physician

Assumes responsibility for assigned minimal and high-risk studies identifies potential protocol