Job Title: Research Coordinator
Effective Date: Jan 2026
Department: South Sound Care Foundation
Reports To: Director of Research
Summary:
The Research Coordinator is responsible for coordinating and supporting clinical research activities involving human participants. This position ensures the accurate collection, documentation, and management of research data in accordance with approved study protocols and applicable federal, state, and institutional regulations, including FDA regulations, Good Clinical Practice (GCP/ICH) guidelines, and HIPAA requirements.
Duties and Responsibilities include the following.
The duties listed below represent the core responsibilities of the position and are not intended to be an exhaustive list:
Coordinate patient participation in clinical research studies in compliance with study protocols, regulatory requirements, and institutional policies.
Screen and identify potential research participants based on protocol-specific inclusion and exclusion criteria.
Assist with the development, implementation, and maintenance of patient screening and enrollment processes across clinics and affiliated facilities.
Coordinate the collection, distribution, and quality control of protocol-required research data to ensure accuracy and completeness.
Prepare and manage central laboratory kits and coordinate specimen collection, processing, and shipment in collaboration with laboratory staff.
Ensure laboratory and diagnostic tests required by study protocols are ordered, scheduled, and completed at required time points, including baseline, interval visits, end-of-study, and follow-up visits.
Review laboratory and diagnostic results and promptly notify investigators or study physicians of abnormal findings in accordance with protocol requirements.
Maintain appropriate inventory levels of investigational products, research supplies, and study materials in compliance with sponsor and regulatory guidelines.
Prepare and maintain study binders, case report forms, and participant charts in accordance with sponsor, regulatory, and institutional requirements.
Complete case report forms and other study documentation accurately and within required timelines.
Coordinate protocol-related activities for participants enrolled in long-term follow-up phases of clinical studies.
Transport research-related documents, laboratory specimens, and supplies as necessary, following applicable safety and confidentiality standards.
Ensure strict confidentiality of protected health information (PHI) and study data in compliance with HIPAA and institutional privacy policies.
Maintain professional, collaborative relationships with investigators, sponsors, monitors, clinical staff, and external research partners.
Perform all duties in accordance with FDA regulations, GCP/ICH guidelines, HIPAA regulations, and institutional policies and procedures.
Maintain accurate and audit-ready research documentation.
Participate in sponsor monitoring visits, audits, and regulatory inspections as assigned.
Complete required training related to human subject protection, compliance, safety, and institutional standards.
Qualifications:
Education/Experience:
High school diploma or equivalent required; associate or bachelor’s degree in health sciences, life sciences, or a related field preferred.
One (1) or more years of experience in clinical research, healthcare, or a related field preferred.
Knowledge of clinical research processes, regulatory requirements, and data collection practices preferred.
Proficiency with electronic health records, research databases, and standard office software.
Strong organizational skills, attention to detail, and ability to manage multiple priorities.
Effective written and verbal communication skills.
Ability to maintain confidentiality and exercise professional judgment.
Computer Skills:
Proficiency in Microsoft Office Suite.
Familiarity with oncology research databases (e.g., ClinicalTrials.gov), EDC systems, and statistical software (SPSS, R, SAS).
Language Ability:
Strong written and verbal communication skills.
Ability to prepare clear reports, grant proposals, and scientific manuscripts for oncology audiences.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This position allows the person to work from home with laptop business equipment and telephone calls.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The work is typically performed at home. While performing the duties of this job, the employee is regularly required to: use hands to handle or feel; talk; see; and/or hear. Employees must be able to work in close contact with small and large groups.
