Freelance Clinical Research Associate at ClinChoice
(View all jobs) Fort Washington, Pennsylvania
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Freelance Clinical Research Associate. You will be responsible for site management (including start-up), both on-site and remotely across the Midwest and West Coast, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
The Senior Clinical Research Associate monitors clinical studies and assures high quality of the clinical data. Experience monitoring oncology and respiratory trials required.
Main Job Tasks and Responsibilities: - Keeps him/herself professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects he/she will be assigned.
- Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
- May act as Feasibility Associate (FEA) after appropriate and documented training.
- Performs training site staff in all study procedures to ensure protocol/ICH-GCP compliance.
- Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP’s and ICH-GCP requirements in order to ensure data integrity and subject safety.
- Attends and may present at Investigator Meetings (IM) and study specific training meetings.
- May translate, coordinate translations or review completed translations of critical documents.
- Conducts source data verification and in-house review of clinical data ensuring timely resolution of data queries to guarantee reliable clinical data.
- Manages the investigational products (storage, inventory, dispensing records, packaging and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
- Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reactions such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues.
- Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
- Is the main contact person for the site in order to ensure close follow up.
- Provides general support to Clinical Operations - NA on quality control of clinical data.
- Promptly addresses the Projects Coordinators (PCs)/ Project Managers (PMs)/ Senior Project Managers (SPMs) about any issues that can jeopardize the conduct of the clinical projects assigned.
- Reports to the Clinical Operations Director or delegate on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each clinical trial.
- Develops training material and gives training to Clinical Operations - NA in collaboration with the Training & Qualification Management Unit (TQMU).
- May assist in contract negotiation with sites on study budget after appropriate and documented training.
- Assists the preparation of the study including CRF design/development, writes CRF instructions, organizes the study files and documents to ensure good start-up of the investigation sites.
- May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. Accordingly, he/she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant.
- Guides and supervises Clinical Research Associates I (CRAs I)/ Clinical Research Associates II (CRAs II) in order to coach and train them on the job.
- Performs co-visits with Clinical Research Associates I (CRAs I)/ Clinical Research Associates II (CRAs II).
Education and Experience: - Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Eight (8) years (at least) of experience as a CRA.
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Sound knowledge of medical terminology.
- Ability to manage more than 1 study simultaneously.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
- Willingness and ability to travel up to 50-80%, this may increase or decrease depending on the project needs.
The Application ProcessOnce you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.
Who will you be working for?About ClinChoiceClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to pharmaceutical, biotechnology, medical device, and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.
Our Company EthosOur employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.
ClinChoice is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status.
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