CRO-Contract Senior Clinical Research Associate

Evolution Research Group• US,

2d•$0 - $110•Remote

About The Position

The Contract Senior Clinical Research Associate (CRA) conducts site monitoring responsibilities for clinical trials, according to Standard Operating Procedures (SOPs), FDA regulations, ICH guidelines, and Good Clinical Practices (GCP). This role involves independently managing and monitoring site activities for assigned clinical studies, working individually or co-monitoring with other CRAs. Monitoring activities include site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with protocols, SOPs, FDA regulations, and ICH-GCP guidelines. The CRA performs site evaluation visits, reviews protocols with site personnel, provides training, and ensures the Investigator Site File is kept audit-ready. Direct communication with investigational sites for planning, query resolution, and action item resolution is key. The role also includes documenting investigational product accountability, stability, and storage, performing inventory, and ensuring return or destruction of unused materials. The CRA serves as the primary contact with the site, coordinating correspondence and ensuring timely transmission of clinical data. Study close-out visits involve final investigational product reconciliation, site file reconciliation, data query resolution through to database lock, and resolution of outstanding action items. Internal and study-related trainings must be completed per timelines, and pre/post-visit follow-ups are required.

Requirements

Bachelor's degree or equivalent experience in life science/healthcare.
At least 5 years of field experience working within clinical research as a CRA.
Mastery of the CRA II Job Responsibilities.
Valid Driver’s License.
Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency.
Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process.
Proficiency in using electronic CRF platforms and processes.
Excellent interpersonal skills.
Exceptional attention to detail.
Ability to interact effectively within and across team environments.
Excellent organizational skills.
Exceptional ability to exercise professional judgment and uphold ICH GCP guidelines and determine appropriate action to a variety of problems of varying complexity.
Strong ability to work effectively and efficiently handling multiple tasks simultaneously.
Consistent ability to manage and meet multiple deadlines.
Ability to work independently.
Proficient computer skills with good working knowledge of a range of standard computer software required (e.g., email, document, spreadsheet, and presentation software).
Ability to submit invoices, expense reports, etc. in a timely manner in accordance with Lotus’s Finance Department requirements.
Contractor shall be responsible for their own insurance.

Responsibilities

Independently manages and monitors site activities for assigned clinical studies, working individually or co-monitoring with other CRAs.
Conducts site qualification, site initiation, interim monitoring, and close-out visits independently.
Ensures compliance with the protocol and applicable Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines during monitoring visits.
Performs site evaluation visits of potential investigators, evaluating the site’s capability to manage and conduct the clinical study.
Performs study initiation activities, reviewing protocols, regulatory issues, study procedures, and providing training on case report forms, monitoring activities, and close-out activities.
Ensures the Investigator Site File is kept audit-ready and ensures documents are collected and uploaded into the Trial Master File on a regular and timely basis.
Communicates directly with investigational sites on visit planning, query resolution, action item resolution, and other site management support.
Documents accountability, stability, and storage conditions of clinical trial materials as required by the Monitoring Plan, and performs investigational product inventory.
Ensures return of unused materials to the designated location or verifies destruction as required.
Serves as primary contact with the site, coordinating all correspondence and ensuring timely transmission of clinical data.
Performs study close-out visits per the study specific Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items.
Ensures internal and study-related trainings are completed per Lotus and/or study timelines.
Completes pre and post visit follow up, including compliance to timelines for Confirmation Letters, Follow up Letters and Monitoring Visit Reports.
Performs other related duties as requested.