Description
Syneos Health is seeking an experienced Clinical Research Associate (CRA) to work remotely in the US.
The successful candidate will have at least 1 year of independent monitoring experience and will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
Key responsibilities include:
- Evaluating overall performance of site and site staff and providing recommendations regarding site-specific actions
- Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Conducting Source Document Review of appropriate site source documents and medical records
- Applying query resolution techniques remotely and on site, and providing guidance to site staff as necessary
- Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifying site compliance with electronic data capture requirements
- Performing investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supporting subject/patient recruitment, retention, and awareness strategies
- Entering data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
The ideal candidate will have:
- A Bachelor's degree or RN in a related field or equivalent combination of education, training, and 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
Syneos Health offers a range of benefits, including a company car or car allowance, health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.
The base salary range for this position is not specified, but actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.