Vanderbilt University Medical Center Clinical Trials Associate II-Pediatric Genetics-FT Days in Nashville, Tennessee
JOB CODE INFORMATION:
- Job Code: 4646
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.
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.
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.
Associate's Degree (or equivalent experience) and 2 years experience
Licensure, Certification, and/or Registration (LCR):
Physical Requirements/Strengths needed & Physical Demands:
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.
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.
Organization: Pediatric Genetics 104590
Title: Clinical Trials Associate II-Pediatric Genetics-FT Days
Location: TN-Nashville-Medical Center North (MCN)
Requisition ID: 1807189