Vanderbilt University Medical Center Clinical Trials Associate I in Nashville, Tennessee

Job Summ ary

This position will provide varied support for clinical trials and research projects within the Emergency Medicine Research Division. This research position will perform a variety of duties involved in the collection, processing, interpretation, storage and documentation of biological and data specimens in support of clinical trials. The role is expected to assist in ensuring adherence to protocols, appropriate regulations, deadline and quality of information received.

Key functions and expected performances include but are not limited to the following:

  1. Assists research coordinators and lead staff in assessing patient eligibility for approved study.

• Knowledgeable of protocols in order to determine specific criteria for eligibility or exclusion.

• Gathers complete medical history of patient.

• Ensures patient consent forms are completed.

• Reviews medical history to determine eligibility status

• Discusses findings with research coordinators and lead staff.

  1. Processes patient data and runs reports as needed.

• Abstracts and records all patient data essential to the study onto required case report forms.

• Sets up timeline of tests and required procedures according to the protocol.

• Inputs all pertinent patient data into database accurately

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

• Reports all adverse reactions according to VU and protocol guidelines

• Checks values from lab and rates toxicity levels

• Ensures complete source documentation in record

• Ensures treatment and dates match

• Assists clinical research coordinators and lead staff with monitoring compliance with protocol and regulations

  1. Ensures deadlines are met for study

• Informs research coordinators and lead staff of tests and procedures as needed

• Schedules shipping of specimens and samples to meet protocol deadlines.

• Coordinates with patient's PCP or testing facility to ensure tests or procedures are conducted as required.

• Prepares kits for procedures, labels tubes, according to each study with specific times and dates for collection.

• Freezes, spins, separates samples, and cultures as necessary. Mails to designated labs.

  1. Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations.

• Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations.

• Answers queries from sponsoring companies.

• Meets with monitors to respond to any question of data validity.

  1. Conducts follow-up of study patients.

• Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life.

• Informs appropriate registry, clinics, and research coordinators of patient status.

• May conduct outside audits of other institutions data.

• Knowledgeable of protocol.

• Examine data and records to ensure compliance with protocol.

Minimum Requirements:

This position requires an associate’s degree and a minimum of one year of related experience. Candidates with technical school completion and related experience are encouraged to apply.

Experience in emergency services, and/or processing of lab samples is strongly preferred.

Additional Information

This is a full-time position; 40 hours per week. Candidates must be able to work 2nd and/or 3rd shifts with weekend and holiday rotations.

Salary is dependent upon education and experience.

Background screens will be performed and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.

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.

Job Research

Organization: Emergency Medicine Research 104791

Title: Clinical Trials Associate I

Location: TN-Nashville-Oxford House

Requisition ID: 1804668