Clinical Trial Associate
2 weeks ago
- 6 week assignment
- bill rate 40$
- 1 day a week onsite in Natick MA
- Trial Preparation and Coordination : Assist in the preparation and maintenance of essential trial documents. Coordinate/schedule meetings related to clinical trial activities and draft meeting agendas, materials, and minutes as required.
- Data Management Support : Assist in data management activities, including data cleaning and query resolution, to ensure accurate and timely collection of clinical trial data. Assist in updating study databases and maintaining accurate records of trial-related activities
- Site Management: Support investigative site activities by monitoring and managing correspondence in the study mailboxes, to address or escalate site-related issues throughout the trial lifecycle
- Regulatory Compliance : Ensure study compliance with Good Clinical Practice (GCP) guidelines, standard operating procedures (SOPs), and regulatory requirements throughout the conduct of clinical trials. Assist in the preparation and submission of regulatory documents to regulatory authorities, as required
- Study Monitoring : Support study monitoring activities by assisting study monitors with required monitoring visit materials and facilitating communication between the sponsor, monitors and investigative sites
- Quality Assurance : Participate in quality assurance activities, including internal audits and inspections, to ensure compliance with regulatory requirements and adherence to quality standards
- Documentation Management : Assist with maintaining accurate and up-to-date trial documentation, including trial master files (TMF), study files, and correspondence with investigative sites and regulatory authorities.
"Bachelor's degree in a relevant scientific discipline (e.g., Life Sciences, Nursing, Biology)
"Minimum of 3 years of experience in clinical research and willingness to learn and develop clinical trial execution skills across functional areas
"Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple tasks simultaneously
"Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams
Preferred Skills :
"Prior experience as a Clinical Research Associate, Clinical Data Manager, Clinical Trial Monitor, Medical Writer, or similar
"Proficiency in the use of electronic data capture (EDC) systems
"TMF maintenance experience
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