Clinical Translational Research Coordinator I

About the Role

Responsible for coordinating the approval processes and conduct of research protocols, maintaining the integrity and quality of clinical/translational research in accordance with all policies, with some guidance.

Key Responsibilities

• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional, departmental, and federal policies and procedures.
• Prepares and maintains documents required for internal and external review (regulatory authorities, sponsors).
• Participates in site visits from sponsors, regulatory authorities, and others to review research, source documentation, and research procedures.
• Procures equipment and supplies needed for project requirements.
• Records data from source documentation and/or participant interaction onto case report forms (paper or electronic), ensuring accuracy, completeness, and timeliness.
• Addresses query resolution in a timely manner.
• Assures research information is collected and stored in compliance with regulations, policies, and Good Clinical Practice (GCP).
• Performs packaging and ships study specimens (blood, urine, etc.) according to sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
• With direction, assists with study completion, study closeout, and archiving of study files, ensuring completeness and continuity of all study data.
• Performs ongoing checks of clinical/translational data entered on case report forms or in reports.
• With supervision, develops and manages study budgets, monitoring invoicing and taking appropriate action to maintain clinical trial billing compliance.
• Serves as an advocate for human subjects by establishing and maintaining communication with investigators, research staff, sponsors, participants, and representatives of professional organizations, participant advocates, and the public.
• Conducts ongoing monitoring of trial processes and participants.
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• With guidance, assesses and evaluates potential participants' pertinent medical and historical information to ensure only appropriate subjects are enrolled and remain eligible.
• Engages in open and positive communication with study participants and coworkers.
• With direction, performs or instructs others in performing research procedures as described in the protocol.
• Deviates from the protocol only when a subject's safety is at risk and reports all deviations to the Principal Investigator and/or senior personnel in a timely manner.
• Additional duties may be assigned.

Technical Capabilities

• Project Coordination (Fundamental Awareness): Light experience, training, direct exposure, or past experience supporting at least one project. Collects and collates project-related materials such as initiation documents, status reports, metrics, and completion data.
• Study Design & Conduct (Fundamental Awareness): Applies qualitative and quantitative research methods for preparatory, regulatory, and analytic tasks within a study's lifecycle.
• Communication (Fundamental Awareness): Communicates clearly, effectively, and respectfully.
• Clinical Research (Fundamental Awareness): Knows primary resources for job accomplishment. Can research simple clinical questions. Files and collates trial documentation and reports. Archives study documentation and correspondence. Demonstrates a systematic approach to problem-solving.

Requirements & Tech Stack

• Project Coordination
• Study Design & Conduct
• Communication
• Clinical Research
• IRB
• Case report forms
• Good Clinical Practice (GCP)

Qualifications

• Education: Bachelor's degree
• Experience: Less than 1 year of relevant work experience.