Vanderbilt University Medical Center Clinical Trials Associate II-Pediatric Genetics-FT Days in Nashville, Tennessee

JOB CODE INFORMATION:

  1. Job Code: 4646

JOB SUMMARY:

Supports the activities of the Principal Investigator in accordance with the protocols and regulations. Involved in the collection, interpretation and documentation of data in support of clinical trials. Conducts off-site audits. Initiates and develops process improvements. Trains and mentors new staff members.

KEY RESPONSIBILITIES:

  • Coordinate protocol and patient consent form process.

  • Coordinates preparation of all IRB and regulatory documents; under direction of PI may draft various communications with Sponsor.

  • Develops assessment tool pre protocol to use in clinical research.

  • May assist PI in obtaining Informed Consent from study participant and documents appropriately.

  • Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary.

  • Processes patient data and runs reports as needed.

  • Processes and ships lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.

  • Develops procedures for lab collection and storage.

  • May provide annual reporting to IRB and prepare annual summaries.

  • Abstracts and records all patient data essential to the study onto required case report forms or into the electronic data collection system.

  • Sets up timeline of tests and required procedures for nurse.

  • Inputs all pertinent patient data into database accurately.

  • Collects and monitors all study patient records to document treatments and outcomes as required by the protocol.

  • Report all adverse reactions according to VU and protocol guidelines.

  • Check values from lab and rates toxicity levels.

  • May coordinate with research investigators, monitors, IRB and sponsors regarding approval process with IRB.

  • Process Improvement

  • Institutes process improvement measures for efficiency and productivity within the dept.

  • Initiates and develops new procedures to improve quality and efficiency in the dept.

  • Trains and mentors new staff to perform job duties at an acceptable level and understand new processes and regulations. Encourages new employees to ask questions to spur process improvement.

  • Pursues professional development and participate on committees, as requested by management.

TECHNICAL CAPABILITIES:

CORE ACCOUNTABILITIES:

CORE CAPABILITIES:

Associate's Degree (or equivalent experience) and 2 years experience

Licensure, Certification, and/or Registration (LCR):

Physical Requirements/Strengths needed & Physical Demands:

Movement

  • Occasional: Sitting: Remaining in seated position

  • Occasional: Standing: Remaining on one's feet without moving.

  • Occasional: Walking: Moving about on foot.

  • Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another

  • Occasional: Push/Pull: Exerting force to move objects away from or toward.

  • Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles

  • Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.

  • Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.

Sensory

  • Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.

  • Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.

  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

Environmental Conditions

Job Research

Organization: Pediatric Genetics 104590

Title: Clinical Trials Associate II-Pediatric Genetics-FT Days

Location: TN-Nashville-Medical Center North (MCN)

Requisition ID: 1807189