Description:

OverviewAssists with study start-up and the preparation and maintenance of all regulatory documents required by sponsor and/or regulatory agencies.Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.Assists clinical research personnel in the implementation of clinical research projects.Assists in the identification and recruitment of eligible study subjects.Helps arrange study visits and provide instructions to study participants/families.Facilitates study initiation, monitoring and close-out visits.May attend investigator meetings.Abstracts data from medical records and enters medical information/data onto protocol specific case report forms (CRF), study flow sheets, and other required study forms.Assists in creating and updating case report forms and/or source document templates.Coordinates reimbursement of subjects.Maintains inventory of supplies/equipment.Prepares lab kits and requisitions prior to visits.Collects specimens from subjects and processes specimens as instructed.Records data on source documents and CRFs and/or electronic web based systems.Conducts literature searches and assists with QA/AC procedures.Assists with adverse event monitoring and reporting.Adheres to research protocol in compliance with applicable institutional, local and feral regulations (OHRP, FDA, GCP, etc.).Helps triage patient questions.Helps maintain all study documents (regulatory binders, source documents, correspondence, etc.).Seizes opportunities to enhance knowledge of research conduct/regulations by attending relevant educational meetings/conferences.Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients.Data Management Responsibilities:Enter data and code in a data dashboard.Assists in creating and updating data spreadsheets.Timely data retrieval from medical records.Prepare data for analysis.Importing and exporting data in various formats.Consenting for expedited/minimal risk studies.Identifies patient eligibility per study criteria. QualificationsHigh School Diploma with two years research experience -or-Associates/two years of College with one year research experience or-Bachelors with no research experience.Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred.Strong organizational and communication skills required.Familiarity with Excel database basics.

Skills:

Clinical research, NEURO, neurology

Top Skills Details:

Clinical research,NEURO,neurology

Additional Skills & Qualifications:

Must have: - Clinical Research Experience - Enrollment/Consenting/ RecruitmentPreferred: Bachelors degreeDetails on the Team: CRC 3: General Neurology (This is a single CRC program as well newly re-started. Formal industry sponsored clinical trial work for pediatric migraines and now rare leukodystrophy disorders. Independent work for 2 different PIs.):CRC 3:Neurocritical Care (NCC) position(This is a single CRC program. Its heavily database driven and retrospective studies. However, more recently were heading back in formal clinical trial work for strokes and neurovascular PI-initiated protocols. Independent work for multiple PIs.):CRC 3: Neuromuscular positions: (At fully staffed 8 CRC team. Team work key as a lead CRC and back-up/assistant CRC are added to each study. Very complex industry sponsored trials. ASOs and gene replacement therapy clinical trials. Also an internal large PI-initiated natural history study of neuromuscular disorders tracking samples and gross motor outcomes overtime/over these therapies

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.