Clinical Studies Coordinator - Gynecologic Oncology

JOB SPECIFIC COMPETENCIES

Coordination of Study initiation and Operations of Clinical Research Protocols

·         Under supervision of the protocol primary investigator (PI), the research nurse manager and/or clinical studies supervisor, assumes responsibility for the overall effective operation and conduct of designated protocols.

·         Collaborates with multidisciplinary team as necessary to document patient care, achieve objectives of protocols, and maintain patient safety; instruct co-workers in allied fields in procedures for recording patient information per protocol.

·         Notifies clinical and/or research laboratories of protocol-required laboratory tests including EKGs, PKs, PDs, urine collection, etc.  Assists in preparing protocol-specific training to ancillary staff (e.g., OR staff) as needed.

·         Collaborates with PI and protocol administration team to collect and develop critical information for protocol submission and revisions. Develops research documents and tools to aid in successfully meeting clinical trial requirements. Participates in development of protocol-specific treatment plans/orders, as required.

·         Provides study enrollment updates in PI meetings or patient-update calls with sponsor; organizes monthly status meeting and prepares all related material for discussion including meeting agenda and project updates; if required for multi-center trials, maintains contact with other participating institutions and coordinates all data pertaining to such studies.

·         Sets up monitoring visits - Schedules the monitor visit and keeps track of all scheduled monitor appointments.

·         Utilizes the OneConnect system to make sure research charges are documented appropriately and that billing to sponsored study accounts is accurate.  Ensure completion of monthly departmental reconciliation process for patient care charges on time in collaboration with department clinical research finance team.

·         Demonstrates excellent oral and written communication skills when contacting patients, physicians, other institutions 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. Responds in a timely manner to queries, data entry, database issues, protocol status, and other events. Participates in training and mentoring of assigned staff.

• Ensures human subjects protection in accordance with federal, state and institutional requirements. Understands and adheres to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at training meetings; attends appropriate departmental meetings and institutional continuing education programs.

Direct support for patient and data management   

·         Acts as liaison with patients, physicians and other research staff in providing administrative and patient care services for the coordination of assigned research protocols, as assigned.

·         Develops and utilizes reports in Epic to filter inclusion and exclusion criteria per protocol to identify eligible study participants. Assesses patients and verifies protocol eligibility through personal interviews and/or medical record review. Keeps detailed screening logs for study team and sponsor review.

·         Provides feedback to physicians and multidisciplinary team regarding required screening activities and scheduling time constraints. Schedules patient tests, keeps patients informed about test results and studies.

·         In collaboration with the Principal Investigator (PI) and/or sub-investigators, responsible for ensuring the informed consent is understood, signed and processed appropriately.

·         Documents study-related data in the patient’s medical record, protocol-specific documents, and institutional reports as required.

·         Follows patients on studies and maintains expert knowledge of adverse events and policies regarding reporting. Submits information on adverse events as well as surgical complications to PI, study sponsors, and/ or the institutional IND office, per protocol.

·         Attends various surgical cases to gather project related data and/or imaging.

·         Monitors and reviews protocol-related labs and procedures, responses to treatment, and adverse drug reactions with the principal investigator and/or study sponsor; communicates determination of dose delays and dose reductions based on protocol criteria to treatment team. Collaborates with the entire medical care team as necessary.   

·         Knowledge of protocol databases and electronic applications; participates in maintaining data and activities to ensure preparedness for industry, institutional, and federal clinical trial audits.

·         Enters research study data into electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines. Addresses data entry omissions or inconsistencies and amends errors in a timely manner.  Communicates research data revision requests to the physician and/or clinical research staff for correction. As needed, obtains patient charts and outside records required for protocol compliance.

·         Prepares and reviews necessary data for monitoring visits, audits, and safety summaries; generates protocol summary reports, and user-generated data reports as requested; assists and compiles protocol and patient data for manuscript submissions, as requested.

Biospecimen Collection and Management

• Collaborates with PI, MD Anderson labs and ancillary teams (OR, pathology, diagnostic labs, etc.) to establish workflows and pathways for the collection and management of protocol required biospecimens. 

·                Assists in development of laboratory manual and specimen handling, processing, and storage, as assigned.

• Coordinates biospecimen collection in the operating room as needed per protocol including requesting and documenting chain of custody in institutional and/or departmental systems.
• Collects, labels, processes, stores, and/or ships blood, tissue, and other body fluid specimens according to institutional and protocol specific guidelines. 
• Assist in retrieval of pathology slides/blocks and mail as specified in protocols in transportation of blood/tissue specimens between lab and clinic as needed by protocol. Duties include communicating with investigator/collaborator to identify appropriate specimen, submitting requests in iLab, contacting external hospitals (as needed), replying to queries, obtaining specimens and tracking the status of specimens for projects/protocols.

• Arrange shipment of sample boxes with a suitable air freight carrier and contact collaborators or sponsor personnel to coordinate shipments and verify receipt of samples.  Responsible for receiving, confirming, and maintaining records of notification/receipt of shipments to sponsor/CRO/MDA labs. 
• Assists in the organization of department biospecimen supply and kit management.

 Other duties as assigned