Description:

　　Job Description:

　　-Responsible for the accurate and timely completion of clinical research subject Case Report Forms.

　　-The Research Data Specialist (RDS) supports the clinical research team.

　　-Responsibilities involve patient registration, data management, adverse event reporting, maintenance of a Clinical Trials Management System, and other activities related to research.

　　-The RDS works closely with the Clinical Research Nurses (CRN) and Clinical Research Coordinators (CRC) to complete all data-related tasks.

　　-The RDS serves as a resource for the clinical research team regarding all aspects of data management to achieve optimal research outcomes and quality.

　　Day to Day:

　　-Independently completes CRFs (paper and electronic) in a timely and accurate fashion in accordance with protocol, regulations, and CRF guidelines.

　　-Obtains, and maintains, database access/training, timely. Responds to data queries in a complete, accurate and timely manner.

　　-Reviews and completes on-site queries and corrections as required during monitor/audit visits in collaboration with research team.

　　-Maintains study supplies (lab kits, radiology/imaging supplies, CRFs, etc.) in accordance with protocol requirements.

　　-Packaging and shipping of biologic samples in compliance with protocol and federal guidelines. May attend research procedures to ensure protocol specific collection of samples (may require travel to various clinics and associated locations).

　　-Assists CRNs and CRCs in retrieving radiology films, lab specimens, hospital records. This may require travel to various clinics and associated hospitals.

　　-Assists department in preparing for audits and monitor visits.

　　-Organizes and maintains study related medical information in the research source document (medical chart).

　　-Maintains subject pre-screen, screening, and on-study information on a concurrent basis using Clinical Trials Management System and other tools as appropriate.

　　-Assists CRN/CRC to manage clinic site study visit calendars while coordinating investigator availability and the availability of any ancillary services required by the study protocol.

　　-Maintains subject follow-up schedules and information as required by the protocol.

　　Skills:

　　clinical research, CRF, Data management, CTMS, patient registration, adverse event reporting, maintenance management, quality management, data review, study protocol

　　Additional Skills & Qualifications:

　　REQUIRED QUALIFICATIONS:

　　Associates Degree from an accredited college or university OR Graduate of an Allied Health Program (Medical Assistant, Certified Nurse Aide, Lab Tech, Infusion Tech, etc) - Bachelors preferred.

　　If not Certified Clinical Research Professional (CCRP) at time of hire, must achieve professional certification through Society of Clinical Research Associates (SOCRA ) by deadline assigned to specific work location.

　　Knowledge and understanding of the clinical environment.

　　Proficient in computer systems with expertise in use of Microsoft Office Suite.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.