Sr. Research Program Coordinator

Specific Duties & Responsibilities:

Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library. Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data. May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol‑ specific case report forms as needed. May also assist less experienced staff in design and creation of such forms. Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems. Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication. Verifies scheduling of patient appointments, tests, and follow‑up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests. Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements. Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed. Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. May participate in the development of invoicing schedules. Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data. Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator. Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.

Minimum Qualifications (Mandatory):

• BA/BS degree in Biological/Social Sciences or other appropriate discipline required. Additional graduate level course work is preferred.

Minimum three years’ experience in complex and detailed clinical trials/medical research required. Proficiency in the use of software pplications, databases, spreadsheets, and word processing required.
• Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.

Licensure, Certification, Registration:

• Certification as a Clinical Research Professional is preferred.

Special Knowledge, Skills, or Abilities:

Excellent organizational skills required. Excellent attention to detail skills required. Knowledge of medical terminology required. Familiar with medical procedure and laboratory fees. Ability to manage multiple and competing priorities. Knowledge of clinical research practices and principles required. Ability to understand a clinical trail financial contract. Must have excellent time management skills. Must have excellent oral and written communication skills.