About The Position

The Associate Clinical Research Coordinator (aCRC) participates in coordinating cancer-related clinical research studies from research planning through study completion. Under the direction of investigators and licensed clinicians, the aCRC works with research nurses, other coordinators, collaborating clinical trial office units, and other study personnel to support protocol compliance and safe, timely study activation. The role includes coordinating study visits and participant schedules, supporting prescreening and patient navigation, and assisting with study documentation and data reconciliation. Assessments and reports requiring licensure must be performed or verified by licensed clinicians as specified in the posting. The position has substantial responsibility for clinical-trial biospecimens and biofluids. Duties include coordinating collection materials and specimen transport; processing, storing, shipping, and tracking samples; maintaining specimen and supply inventories; documenting specimen information in records and databases; and addressing data queries or missing specimens. The aCRC also supports laboratory organization, specimen quality control, feasibility reviews, site-initiation activities, training, audits, SOP development, billing data entry, and quality improvement. Work is performed in accordance with institutional and CTO procedures, CAP accreditation requirements, Good Clinical Practice, applicable human-subject research regulations, and safety requirements.

Requirements

  • Bachelor's degree or an equivalent combination of education and experience.
  • At least 1 year of relevant experience as a research coordinator with biospecimen processing, or laboratory or clinical experience.
  • Computer literacy and proficiency with Microsoft Office applications, including Word, Excel, Access, PowerPoint, and Outlook; familiarity with internet applications.
  • Intermediate competency in medical terminology and advanced competency in Good Clinical Practice guidelines, federal regulations governing human-subject research, and relevant IRB and institutional policies and procedures.
  • Strong time-management skills and ability to work under pressure and meet deadlines.
  • Effective oral and written communication and interpersonal skills.
  • Ability to work in a team and independently under a supervisor's direction, make decisions in a team setting, and identify, analyze, and solve problems.
  • Ability to communicate effectively with all levels of the organization.

Nice To Haves

  • Prior experience with centrifuges and handling biofluid specimens.
  • Bachelor's degree, preferably in science, public health, health education, or a related field.
  • Professional certification such as ACRP CCRC or SOCRA CCRP.

Responsibilities

  • Work with licensed clinicians to create and maintain tracking forms for active trials and communicate workflow or protocol changes to study team members.
  • Schedule participants and coordinate ancillary services to support adherence to approved protocols.
  • Prepare for study visits, including bio-specimen collection materials, research tickets, laboratory and EKG orders, biopsy and scan scheduling, and study forms in conjunction with licensed professionals.
  • Serve as the primary point of contact for bio-specimen collections and facilitate provision of collection materials to study personnel and infusion nursing.
  • Compile and submit weekly pharmacy lists; monitor infusion chair assignments and request changes as needed to meet protocol requirements.
  • Help reconcile clinical data discrepancies with research data associates and coordinators.
  • Maintain follow-up calendars and complete assessments that do not require licensure; may perform EKGs after documented training.
  • Coordinate vial assignments with the DCU, infusion nurses, and pharmacy to support timely investigational product dispensing.
  • Participate in prescreening to identify potentially eligible patients and collaborate with other coordinators on patient navigation to studies.
  • Administer ancillary assessments under licensed-clinician supervision and help patients understand protocol schedules and coordinate appointments and services.
  • Under investigator supervision, assist with adverse-event and concomitant-medication documentation and reporting; ensure required clinician review and signature before submission.
  • Write research notes in EPIC without making clinical assessments and help compile enrollment packets for review and signature by the research nurse and investigator.
  • Maintain knowledge of study designs and specimen collection procedures, and complete required biological-hazard training for handling, packaging, and shipping human biofluid samples.
  • Respond promptly to requests for collection materials and use established procedures and resources to resolve problems.
  • Maintain clean laboratory facilities and shared bench spaces and share general laboratory responsibilities.
  • Monitor transport and receipt of research biofluid samples; centrifuge, process, prepare, ship, and store biological materials according to sponsor protocols, institutional procedures, safety requirements, and universal precautions.
  • Perform bench work and advanced specimen-processing techniques as needed, with direct supervision where required.
  • Manage specimen and collection-supply inventories for multiple studies, including specimen quality control before distribution.
  • Collaborate with hospital and medical-school personnel, including research nurses, infusion nurses, phlebotomists, program managers, regulatory staff, and laboratory personnel.
  • Attend site-initiation and monitoring visits related to specimen requirements as needed.
  • Record and maintain confidential biospecimen information on paperwork and web-based forms; correct queries and missing or inaccurately reported specimen data promptly.
  • Maintain complete specimen records in enterprise databases and organized, current biospecimen files and documentation.
  • Perform work in accordance with institutional and CTO SOPs, CAP accreditation, applicable guidelines, work instructions, and Good Clinical Practice standards.
  • Support clinical trial feasibility reviews, site-initiation meetings, and trainings for the central laboratory.
  • Assist with repository audits, SOP and work-instruction development, policy changes, education sessions, quality-improvement projects, and monthly research and clinical study billing data entry.
  • Collect, process, store, and distribute biospecimens for clinical trials, biobanks, and research studies; enter specimen data in LabVantage/FileMaker Pro.
  • Consent patients for research studies.

Benefits

  • Comprehensive benefits and wellness package
  • Financial security benefits
  • Generous time-off program
  • Employee resource groups for peer support
  • Holistic employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being
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