Research Clinical Assistant

American Oncology Network, Inc.; Fort Wayne (IN); On-site; USD 25,000 - 41,000; Full time

Job summary

American Oncology Network, Inc. seeks an Administrative Support for the clinical research department in Fort Wayne. The role provides clerical assistance, manages communications, and helps prepare study documents under GCP/ICH guidelines.

The position supports investigators and staff across studies, ensuring accuracy and timely execution of tasks. The ideal candidate holds a high school diploma with some college, 1–2 years in research or medical settings, and strong MS Office skills.

Qualifications

• Requires high school diploma; some college preferred.
• 1–2 years in research or related medical science experience preferred.
• Proficiency in MS Office; strong organizational skills.
• Valid driver's license for travel to satellite offices as needed.

Responsibilities

• Maintain knowledge of research processes and GCP/ICH guidelines.
• Assist with centralized study data collection and submission processes.
• Prepare study documents, logs, and master files for quality and audit readiness.
• Support audits and inspections; ensure regulatory and site policy compliance.

Skills

Administrative support

Attention to detail

Communication

Time management

Bilingual (asset)

Education

High school diploma

Some college preferred

Clinical research certification preferred

Tools

MS Office Suite

EMR systems

EDC

CTMS

Job description

Location:Fort Wayne Medical Oncology and HematologyPay Range:$17.93 - $29.89Job Description Summary:Responsible for various support tasks for the clinical research department. Provides administrative and clerical support to the clinical research team.Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.Primary Key Performance AreasKPA 1 – Maintains working knowledge of research processRemains knowledgeable and demonstrates compliance with GCP/ICH guidelines, SOPs and individual protocolsAttend all study initiation meetings and complete ongoing GCP and protocol-based trainingsManages fax and e-mail communications in a timely mannerActively seeks clarification to study processes when neededKPA 2 – Ensures accurate and timely collection and submission of centralized study assessments (radiology, pathology, laboratory, EKG)Maintains inventories for all clinical trial supplies, including restock for any study that is actively enrolling or has active patients.Facilitates destruction of expired or unused supplies in accordance with site policy and study protocol.Prepares supplies needed for patients in advance of scheduled appointments.Completes requisitions and shipping of lab samples collected and processed by the clinicSupports the collection and submission of central radiology data/images per protocol and study manualsSupports the collection and submission of archival tissue Per protocol and study manualsSupports the collection and submission of EKG tracings per protocol and study manualsCompletes Source Documents, Study Documents, Logs, and Master Files to ensure quality, completeness, and accuracyKPA 3 – Support ongoing clinical trial operations including monitoring and quality audit functionsEnsures that written and verbal communication with co-workers, sponsors, and other professionals in the pharmaceutical research field are collaborative and courteousMaintain, update, and distribute research information and training documents to staff and investigators as instructedReviews monitor follow-up letters and ensure outstanding issues are resolved where applicablePrepare and support quality audits and inspections as neededEnsure that adequate and accurate records are maintained in the patient medical record and study regulatory filePosition Qualifications/RequirementsEducation:.High school education requiredSome college is preferredCertifications/Licenses:Professional clinical research certification is preferredValid state Driver’s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.Previous Experience:1-2 years prior research or related medical science experience preferredCore Capabilities:Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.Computer Skills:Proficiency in MS Office Word, Excel, Power Point, and Outlook required.Prior experience with electronic medical records (EMR) is preferredPrior experience with clinical trial data entry systems (EDC) preferredPrior Clinical Trial Management Systems (CTMS) preferred.Travel: 0%Standard Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM.#AONC