Sr. Research Program Coordinator II

Project Management: (75%)
1. Pre-study: anticipates research requirements for designated patient populations • With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety • With guidance, lists & clarifies concerns and questions about new protocols with PI and sponsor • With guidance, evaluates the impact on and availability of resources for assigned clinical trials • Reviews prospective reimbursement analysis (PRA) as appropriate.

2. Pre-initiation: • As appropriate & with guidance, prepares & submits application and consent forms to the IRB • With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, lab requisitions, etc.) • Determines that IRB approval has been received prior to initiation of research activity • Participates in study initiation meetings • Prepares space for study-related equipment & supplies.

3. Recruitment & enrollment: Ensures initial & ongoing eligibility of all subjects for assigned research studies: • Screens potential research subjects for participation in clinical trials (including: Review of medical history, concomitant meds, pathology, other relevant documents) • Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate; • Abstracts data from a variety of sources to complete pre-study work-up • Demonstrates understanding of the informed consent process • With guidance & as appropriate, obtains informed consent from research subjects • As appropriate, documents obtaining of informed consent in medical record • Registers research subjects per sponsor guidelines • In conjunction with PI, monitors protocol enrollment goals • Demonstrates knowledge of protocol endpoint definitions • In collaboration with healthcare team, evaluates potential subjects for research participation.

4. Data collection/Document maintenance: Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials: • Obtains & ensures proper distribution of required pharmacokinetic & tissue samples • Schedules, performs, and/or monitors procedures & tests per protocol requirements • Ensures correct documentation of clinical study in medical record and appropriate protocol documents. Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner • As appropriate, ensures all required signatures are obtained on informed consent documents • As appropriate, ensures validity of available informed consent documents • Maintains clinical research management system (CRMS) data base for enrollment • Reviews protocol amendments as required • Develops procedure and collection forms for pharmacokinetic sampling • With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment. • Coordinates with data managers to ensure delivery of trial data for inclusion into study files • As appropriate, & with assistance as needed, orders required medical equipment & supplies • Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data • With guidance, organizes own time & sets priorities for research-related functions • With guidance, able to prioritize workload & manage multiple projects effectively • Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions • Aware of & knowledgeable about departmental Standard Operating Procedures.

5. Quality Assurance: Evaluates outcomes of assigned clinical trials: • Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB • Ensures that appropriate team members grade identified toxicities per specified grading tables or protocol-specific criteria. • Attends staff meetings to review study progress • In collaboration with other members of the research team, prepares for and responds to study audits.

6. Communication • With guidance, assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups • Documents written & verbal communication with study contacts • communicates effectively with subject & family of active and prospective study participants • Communicates effectively with members of the health care and research teams. • Meets regularly with other members of the research team to review protocol progress and data collection • Attains proficiency in Web-based communication • Demonstrates understanding of the rules for advertising for subject participation, where appropriate.

Education: (10%)Ensures that patient and staff education needs are met with regard to assigned protocols.

1. Patient/Family Education • Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials • Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs.

2. Staff Education • Identifies staff learning needs, including those based on requirements specific to designated research protocols • Ensures development & availability of appropriate staff education materials • Provides staff education related to assigned clinical trials (i.e., in-services) • Attends and participates in in-service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development.

Quality Management Activities: (15%)Reviews source documents and CRFS completed by other study team members for thoroughness and accuracy Provides feedback and ensures that appropriate corrections are made.