Clinical Research Coordinator I - RI Biobeh Gerhardt

Overview:

A full-time Research Coordinator is being recruited for a collaborative research team that is focused on examining family adjustment to children’s life-threatening conditions, such as cancer. The successful candidate will contribute to ongoing work with children and adolescents with cancer. Duties will involve direct work with research participants (recruitment, in-person data collection) in the hospital, schools, and family homes, as well as study coordination. Specific tasks may include: helping with IRB protocols, helping to execute study visits, interviews, data management and analyses, and dissemination of research results. This position will involve close collaboration with the investigators as well as other research staff at NCH and medical staff at NCH/Ohio State University. Several opportunities exist for mentorship and professional development for applicants who may be interested in gaining experience that will prepare them to apply for advanced graduate programs in medicine or psychology. A two-year commitment is required. Some evening and weekend hours may be required to accommodate data collection efforts. Applicants are encouraged to submit resumes with sufficient detail to demonstrate their academic record (i.e., college GPA) and relevant research or work experience. Cover letters are encouraged. The Clinical Research Coordinator’s primary responsibility is managing elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.

Why Nationwide Children's Hospital?:

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose.

Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

We’re 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children’s Hospital. A Place to Be Proud.

Responsibilities:

PRINCIPAL DUTIES AND RESPONSIBILITIES

Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:

Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; adheres to good clinical practices.

Prepares and processes human specimens for use in research studies, if applicable to the study. Collects blood, urine, and other samples as needed according to skill level and certifications, if needed for the study. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours.

Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable)

Assists in the recruitment plan and the in cost estimation; manages screening sheets and recruitment logs, and completes recruitment summary at study termination.

Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,

Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I;

Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations;

Adheres to departmental quality control guidelines

Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria (prior to randomization for drug studies); verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;

Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training.

Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.

Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.

Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.

Assists the principal investigator in the preparation of scientific publications and grant proposals.

Coaches and mentors new clinical research coordinators.

Performs other duties and maintains flexible schedule as required by a protocol or unit needs.

Qualifications:

REPORTING RELATIONSHIPS Reports to: Department Manager

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Bachelor’s degree in psychology or other health or clinical research related fields

A minimum of two years of clinical research experience.

Strong interpersonal skills including the ability to engage participants effectively over the telephone and in person.

Ability to actively participate as a team player, track participant progress, maintain relationships with families, think creatively, work independently, and meet deadlines.

Familiarity with statistical and data management software (e.g., SPSS, Excel, RedCap).

Strong organizational skills and attention to detail.

Ability to handle sensitive topics and confidential data appropriately.

Excellent writing skills and ability to produce clear and succinct reports based on study progress.

Current driver’s license and insurance with access to a reliable car for use in data collection.

MINIMUM PHYSICAL REQUIREMENTS

Talking on phone/in person; frequently (34-100%)

Sitting; frequently (34-100%)

Standing/Walking; frequently (34-100%)

Lifts objects weighing up to 25 pounds; occasionally (0-33%)

Typing on keyboard; occasionally (0-33%)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

Permanent