Research Associate Position
3 weeks ago
The Research Associate will provide support to the Clinical Trials Office, coordinating clinical research trials, meeting with drug company representatives, screening, recruiting, and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing laboratory and other tests as required by the protocol.
Responsibilities- Coordinate clinical research trials, including meeting with drug company representatives, screening, recruiting, and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing laboratory and other tests as required by the protocol.
- Complete all reports, including the annual study continuation report, in a timely manner, accurately communicating 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.
- 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.
- Adapt workflow to accommodate study amendments and principal investigator directions, receive and respond to all correspondence received in a timely manner, keep investigators informed of patients' condition, and provide assistance to investigators in the management of adverse events.
- Attend meetings, computer trainings, and workshops as requested, perform all other related duties as assigned.
- 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.
- 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, previous supervisory experience.
- Completion of Citi Program (Learner group 1 FDA regulated research), CCRC, CCRA, or CCRP certification is highly desirable, BLS certification is a plus.
- Proficient in Microsoft Office and other computer software/databases.
- Excellent interpersonal, written, and verbal communication skills, detail-oriented with strong organizational skills.
- Ability to maintain confidentiality, ability to work early/late hours, nights/weekends, and up to two weeks on call a month, ability to convey information in a professional manner which will most often involve sensitive patient data or other information, must be able to communicate in a non-abrasive manner, ability to work as a team player and adjust daily schedule in order to accommodate patient and investigator schedules.
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