Open Position
Title: Clinical Research Associate
Location: Remote, Regionally Based
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in Morrisville, NC, New York City, and Edison, New Jersey. For more information, visit www.tgtherapeutics.com.
Role
Clinical Research Associate (CRA) reports to the Associate Director, US Site Monitoring. He/she responsible for the successful performance of monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, TG Therapeutics, Inc. standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements.
Key Responsibilities
Responsible for all activities related to implementation and execution of clinical studies that include:
– Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP, monitoring plan and protocol compliance.
– Conduct source document review of appropriate site source documents and medical records. Verify that the required clinical data entered in the case report form is accurate and complete and utilizes query resolution techniques remotely and on-site.
– Perform investigational product (IP) inventory and reconciliation, reviewing receipt, storage, and security Verify IP dispensation, destruction/return, and accountability according to study manuals or study expectations.
– Verify site informed consent process is adequately performed and documented for each
– Routinely review the Investigator Site File for accuracy, timeliness, and completeness. Reconcile the Investigator Study File (ISF) with the Trial Master File (TMF) and collect any outstanding documents.
– Serve as primary point of contact with study site personnel. Document all activities and communications with the site including follow-up letters, monitoring visit reports, routine site communications and other required project documentation. Follow up on action items to ensure timely completion.
– Train site staff on protocol, study procedures, EDC and any other study specific requirements or systems
– Prepare for and attend meetings. Participate in clinical monitoring/project staff meetings and attend clinical training sessions according to the project specific requirements.
– Prepare and coordinate documentation with site for IRB applications and renewals, as
– Routinely communicate with project teams, escalating issues and developing action plans.
– Complete and submit timesheets and expense reports.
– Adherence to Standard Operating Procedures, Policies and Working Instructions (as applicable).
– May serve as a mentor or trainer for junior level CRAs.
– Professionally represent TG Therapeutics in business interactions
Professional Experience/Qualifications
––Must have a minimum of 3 years of prior experience as a Clinical Research Associate
––Ability and willingness to travel domestically 20%-80%
––Must have thorough understanding of current ICH/GCP and FDA regulations pertaining to clinical research.
––Working knowledge of clinical research process.
––Strong communication skills (verbal and written) to express complex ideas.
––Excellent organizational and interpersonal skills.
––Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
––Ability to manage multiple priorities within various clinical trials.
––Understanding of basic data processing functions, including electronic data capture.
Education
––BS/BA (or equivalent) in one of the life sciences with a minimum of 3 years direct experience in clinical studies or equivalent level of education and experience.
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.