Non-IT

Clinical Research Coordinator

Contract

Medasource

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Position: Clinical Research Coordinator

Location: Nashville, TN, 100% onsite

Start Date: ASAP

End Date: 6 months contract-to-hire

JOB SUMMARY

Advanced knowledge and understanding of the planning, implementation, and management of research operations. Responsible

for planning and management of the approval, implementation, and conduct of research protocols from planning through

completion and reporting, assuring that the processes, integrity, and quality of the research are assessed and maintained and

that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines,

Client Policy and Procedure and research protocols. Serves as a resource for inquiries and maintains communication with

the Investigators, participants, sponsors, IRBs, DSMBs, and other research-related entities. Functions as a departmental resource

in research operations.

KEY RESPONSIBILITIES

  • Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, budgets, and D&H accounts
  • Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations
  • Advanced knowledge of the policies and procedures and requirements of Client departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver through the approval processes and then assure compliance throughout the research process
  • Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
  • Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures. Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. Problem solves when needed
  • Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during, and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews
  • Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
  • Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner
  • Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools
  • Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects, and reports adverse events meeting the requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
  • Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
  • Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation

BASIC QUALIFICATIONS

  • Bachelor's Degree (or equivalent experience) (Required)
  • 5 years experience (Required)

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2106-112017

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