"Research Associate - Clinical Trials Office"

Job Summary

The Research Associate conducts research responsibilities for assigned studies. Be familiar with study protocols, assist investigators with recruiting patient studies. Screen potential patients, help enroll and randomize patients with into studies. Collect and enter study data, prepare and maintain regulatory documents, resolve data queries. Schedule patient visits and procedures, perform or assist with venipuncture, prepare specimens for shipment. This position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO).

Responsibilities

Responsibilities to include, but are not limited to:

• Coordination of clinical research trials to include meeting with drug and device company representatives, screening, recruiting and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing all laboratory and other tests as required by the protocol.
• Attend meetings, computer training, and workshops as requested.
• Keep investigator informed of patients' condition and provide assistance to investigators in the management of adverse events.
• Receive and respond to all correspondence received in a timely manner.
• Complete all reports including the annual study continuation report in a timely manner ' accurately communicate all necessary information to patients, families, investigators, sponsors, IRB, and institutional entities.
• Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies as well as the Annual IRB Continuation Reports and other IRB activities as requested.
• Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.
• Enter data into the OnCore research data management system as dictated per institutional policy as well as the Greenphire patient debit system.
• Review study bills received for accuracy ensuring that the correct codes are used and the correct amount is billed according to the billing grid for that study in a timely manner.
• Perform all other related duties as assigned.

Required Qualifications

Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research. OR Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience.

Knowledge, Skills, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and other computer software/databases.

SKILLS

Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong multi-tasking and prioritization.

ABILITIES

Ability to maintain confidentiality. Ability to recognize potential adverse events and follow SOPs for reporting of such. Ability to follow protocols as designed, remember protocols, and communicate with patients. Ability to adapt workflow to accommodate study amendments and principal investigator directions. Ability to work as a team player and adjust daily schedule in order to accommodate patient and investigator schedules. Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month. Ability to communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information. Must be able to communicate in non-abrasive manner.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $45,400-$56,700 annually.