Support clinical research activities for multiple research projects.
Recruit subjects for participation in studies, facilitate patient care, prepare the case report form (CRF), submit CRFs and other data to the sponsor as necessary and facilitate study close-out.
Assemble lab kits and other supplies in preparation to obtain required biospecimen samples and transport to appropriate laboratories for processing; ship samples externally according to IATA requirements.
Provide support (including administrative/clerical) and information to subjects, staff, and external sources related to current research projects.
Maintain scheduling of pre-study testing, treatments, outside labs, scans, biopsies, and other tests for all clinical research visits.
Attend meetings and conferences related to research activities.
Maintain appropriate records of clinical activities.
Support clinical research billing reconciliation activities.
Support the identification of research subjects as they utilize services throughout MemorialCare. This will include flagging/notifying registration and/or appropriate patient accounts personnel to foster proper research coding and billing pursuant to research billing practices.
Demonstrate the ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through.
Understand applicable regulations and implications for trial participation to include knowledge of FDA regulations and GCP guidelines.
Demonstrate strong written and verbal communication skills. Ability to establish and maintain positive study participant, project team member and internal relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
Escalate issues in a timely manner and communicate outcomes effectively across impacted team members.
Demonstrate ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
Maintain working knowledge of current protocols and internal SOPs.
Provide excellent customer service experience for patients; responding to patient needs in a timely manner.
Provide investigators with guidance regarding protocol requirements.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data Safety Review Committee.
Assist with preparation and conduct of audits, inspections, and monitoring visits from regulatory agencies and sponsors.
Attend continuing education and training opportunities relevant to job duties.