Contract Senior Clinical Research Associate

Purpose

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).

Essential Duties and Responsibilities

• Independently manages and monitors site activities for assigned clinical studies, working individually or co-monitoring with other CRAs.
• Monitoring activities include site qualification, site initiation, interim monitoring, and close-out visits, completed independently.
• Ensures compliance with the protocol and applicable SOPs, FDA regulations, and ICH-GCP guidelines during monitoring visits.
• Independently and proficiently performs site evaluation visits of potential investigators.
• Thoroughly evaluates the site's capability to successfully manage and conduct the clinical study.
• Expertly and independently performs study initiation activities, reviewing protocol, regulatory issues, study procedures, and provides training on case report forms, monitoring activities, and study close-out activities.
• Ensures the Investigator Site File is kept audit-ready and documents are collected and uploaded into the Trial Master File regularly and timely.
• Has direct communication with investigational sites on visit planning, query resolution, action item resolution, and other activities to support site management.
• Independently documents accountability, stability, and storage conditions of clinical trial materials as required by the Monitoring Plan.
• Performs investigational product inventory and ensures return of unused materials or verifies destruction as required.
• Serves as primary contact with the site; coordinates all correspondence; ensures timely transmission of clinical data with the study site.
• Expertly and independently performs study close-out visits per the 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 timelines.
• Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan for Confirmation Letters, Follow up Letters and Monitoring Visit Reports.
• Performs other related duties as requested.

Supervisory Responsibilities

Position does not require direct supervision over other team members; however, position may require collaboration with the CRA Line Manager to support the mentoring, training, and assessment of CRAs and junior staff as applicable.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ability and willingness to travel up to 100% of the time (land and air), both domestically. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

Bachelor's degree or equivalent experience in life science/healthcare is required accompanied by 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.

Skills and/or Abilities

• 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 Finance Department requirements.
• Contractor shall be responsible for their own insurance.