[Hiring] Senior Clinical Research Associate @Evolution Research Group

Role Description

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 but are not limited to:
  • Site qualification
  • Site initiation
  • Interim monitoring
  • Close-out visits
• Ensures compliance with the protocol and applicable Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines during monitoring visits.
• Independently performs site evaluation visits of potential investigators, evaluating the site’s capability to manage and conduct the clinical study.
• Performs study initiation activities, reviewing protocol, regulatory issues, study procedures, and providing training on:
  • Completion of case report forms
  • Monitoring activities
  • 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.
• Maintains direct communication with investigational sites on:
  • Visit planning
  • Query resolution
  • Action item resolution
  • Other activities to support site management
• Documents accountability, stability, and storage conditions of clinical trial materials as required by the Monitoring Plan.
• Serves as primary contact with the site; coordinates all correspondence; ensures 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
  • Resolution of outstanding action items
• Ensures internal and study-related trainings are completed per Lotus and/or study timelines.
• Pre and post-visit follow-up includes compliance to timelines indicated in the Monitoring Plan for:
  • Confirmation Letters
  • Follow-up Letters
  • Monitoring Visit Reports
• Performs other related duties as requested.

Supervisory Responsibilities

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

Qualifications

• Bachelor's degree or equivalent experience in life science/healthcare is required.
• 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 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.
• 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 standard software (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.

Physical Demands

The physical demands described here are representative of those that must be met by a contractor to successfully perform the essential functions of this job. While performing the duties of this job, the Contractor regularly reaches with hands and arms, and may be required to lift and/or carry up to 10 pounds. Occasionally, the contractor stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required include close vision, color vision, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those a contractor encounters while performing the essential functions of this job. May work in a clinical research site environment, a travel environment, or in a home office environment. Contractor may be subject to many interruptions, pressure due to deadlines, and handling multiple tasks simultaneously.

Safety Requirements

Contractor is required to pay particular attention to safety practices when traveling and/or visiting a clinical research site, including following all safety, environmental, and infection control guidelines, procedures, and protocols.