CRA II or SR CRA (Home base, Sponsor Dedicated)Updated:December 24, 2024
Location:Malaysia-Asia Pacific - MYS-Home-Based
Job ID: 24007092
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Job Summary:
The Senior Clinical Research Associate I (SCRA I) will perform 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, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
Job Responsibilities:
Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
May act as primary liaison with project site personnel.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Qualifications
What we're looking for:
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
CRA II: 2 years of monitoring experience.
SR CRA: 4 years of monitoring experience.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Syneos Health is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.#J-18808-Ljbffr