Freelance Clinical Research Associate

ClinChoice•New York, NY

About The Position

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking an experienced Freelance Clinical Research Associate (CRA) to support sponsor-dedicated monitoring activities for early-phase oncology clinical trials. This opportunity is open to candidates located in the New York, New Jersey, or Philadelphia regions who are willing to travel up to 70% to investigative sites. The position is offered on a 1099 independent contractor basis, and candidates must have direct experience monitoring studies involving CAR T-cell therapy. ClinChoice is a global, full-service CRO committed to delivering high-quality clinical development services while fostering professional growth and a collaborative, supportive work environment.

Requirements

University Degree in scientific, medical or paramedical disciplines.
Eight (8) years (at least) of experience as a CRA.
Advanced oncology experience required, including experience with early phase oncology trials.
CAR T experience is required.
Proven experience as a CRA, performing on-site monitoring activities.
Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
Fluent in English.
Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
Candidates must be eligible to work on a 1099 independent contractor basis.
Willingness to travel 70% of the time.

Responsibilities

Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites.
May act as Feasibility Associate.
Train site staff in all study procedures.
Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
Act as the main contact person for the site to ensure close follow up.
Provide general support to the Clinical Research Division on quality control of clinical data.
Address appropriate team members about any issues that can jeopardize the conduct of the clinical projects assigned in a timely manner.
Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
Develop training material and give training in collaboration with the Training & Qualification Management Unit.
May assist with contract negotiation with sites on study budget after appropriate training.
Assist with the preparation of the study, including CRF design/development, write CRF instructions and organize the study files and documents to ensure good start-up of the investigation sites.
May support the submission process in the project including submission requirements, timelines, informed consent development, etc.