This position will provide overall direction for the initiation, monitoring, completion and reporting of clinical studies and quality improvement databases and projects in the Division of Neonatal-Perinatal Pediatrics. Responsible for budgetary and fiscal management, quality assurance, database maintenance, proper documentation and reporting, and compliance with various policies and regulations.
Primary Responsibilities Include:
Develop and coordinate departmental policies and procedures to ensure the efficient operation of both clinical trials and patient care. Establish standard operating procedures for the clinical research unit and ensure compliance with all internal and external requirements of regulatory agencies. Train/educate the ancillary staff regarding the clinical trial. Assist with the orientation and training of new staff.
Identify potential subjects from review of existing protected health information based on inclusion/exclusion criteria. Identify, schedule screening procedures and review results; recruit subjects and keep accurate records; obtain patient consent including discussion of treatment/intervention alternatives and signature on Informed Consent forms. Determine appointments with parents, study subjects, families, and medical staff per protocol. Serve as an advocate for the subjects and their family. Prepare for monitor visits; record, document and report protocol deviations; facilitate and participate in pre-study visits with sponsor. Act as liaison between the research staff and the sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators.
Establish and implement a QA/QI system for department. Participate in peer-reviewed, inter-office quality assurance program that retrospectively evaluates accuracy and timeliness of study completion, and protocol violations. Participate and serve as unit representative on appropriate University committees, work groups and task forces.
Initiate and maintain all aspects of IRB including initial submissions, annual updates, adverse events, safety reports, protocol amendments, Informed Consent modifications, etc.
Extract data from source documents and complete Case Report Forms (CRF) or database entries. Order and receive drug/device supplies as directed. Capture and record adverse event data. Manage handling and processing of laboratory specimens. Maintaining sample/specimen tracking and inventory. Order and receive drug/device supplies. Prepare and present project protocol reviews at monthly meetings. Review on-going study subjects on a daily basis. Design and implement secure and separate databases to collect outcome data and track data collection or oversee design of such databases. Maintain master list of all projects and subject participation at sites.
Attend, present and reside over weekly informative conferences to better understand signs/symptoms and diagnosis for current patients, able and willingness to take call when needed as a shared responsibility within the team. Expand knowledge base and keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences.
Act as liaison between the research staff and the sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Prepare marketing materials, search for potential referral services within the community and contact and/or network with sponsors for new grants or contract funding.
REQUIRED: Master's Degree from an accredited institution, plus 4 years clinical research experience; OR Bachelor's Degree, plus 6 years clinical research experience. Must have a Clinical Research Certification (ACRP or SOCRA) and supervisory experience.
Knowledge, skills and abilities:
To be successful in this role, the candidate should be able to learn database organization and data definitions and to supervise others to manage and maintain databases; have knowledge of Standard Operating Procedures, International Conference on Harmonization Good Clinical Practices, and Federal Regulations; Understand quality improvement and clinical research projects within an inpatient and outpatient setting; ability to supervise, organize and prioritize responsibilities; have extensive interpersonal skills, and be willing to develop relationships with the patients and families participating in the research trials; be able to understand project protocols, design, and procedures and then assist in translating them into IRB submissions; be able to evaluate the protocol, study design and risk to subject population; be able to work in a cooperative setting to supervise initiation of quality improvement projects and clinical research studies at the site; and develop the tools necessary to assist health care personnel carry out the trial in an effective and efficient manner.
Salary Plan: PAE
Salary Grade: 4RS
Campus: IUPUI - Indianapolis
Department: PED-NEONATAL MEDICINE (IN-PNEO-IUINA)
Internal Number: 66395
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.