[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 will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits, completed independently.
• Ensures compliance with the protocol and applicable Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines during monitoring visits.
• Independently and proficiently performs site evaluation visits of potential investigators, evaluating the site’s capability to manage and conduct the clinical study.
• Expertly performs study initiation activities, reviewing the protocol, regulatory issues, study procedures, and providing training on case report forms and monitoring activities.
• Ensures the Investigator Site File is kept audit-ready and documents are collected and uploaded into the Trial Master File on a regular basis.
• Maintains direct communication with investigational sites on visit planning, query resolution, and action item resolution.
• 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 and ensures timely transmission of clinical data.
• Performs study close-out visits per the Monitoring Plan, including final investigational product reconciliation and data query resolution.
• 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.
• Performs other related duties as requested.

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.

Requirements

• 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 and exceptional attention to detail.
• Ability to interact effectively within and across team environments.
• Excellent organizational skills and ability to exercise professional judgment.
• Strong ability to handle multiple tasks simultaneously and meet deadlines.
• Ability to work independently and proficient computer skills with standard software.
• Ability to submit invoices and expense reports in a timely manner.
• 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.

• Regularly reaches with hands and arms; may lift and/or carry up to 10 pounds.
• Occasionally stoops, bends, kneels, and crouches; 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 with moderate noise levels.
• May work in a travel environment with moderate to high noise levels.
• May work in a home office environment with largely controlled noise levels.
• Subject to interruptions and pressure to meet deadlines while handling multiple tasks.

Safety Requirements

Contractor is required to pay particular attention to safety practices when traveling and/or visiting a clinical research site.

• Follow all safety, environmental, and infection control guidelines, procedures, and protocols.
• Wear appropriate safety/protective equipment.
• Practice safe use of cell phones and other mobile devices while driving on Company business.