CRO-Contract Senior Clinical Research Associate

About the Role

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).

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, and close-out visits.
• 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 successfully manage and conduct the clinical study.
• Expertly and independently performs study initiation activities, reviewing protocol, regulatory issues, study procedures, and providing training on completion of 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.
• Communicates directly 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, ensures return of unused materials to designated location, or verifies destruction as required.
• Serves as primary contact with the site, coordinates all correspondence, and ensures timely transmission of clinical data.
• Expertly and independently performs study close-out visits per the study-specific Monitoring Plan, including final investigational product reconciliation, site study file reconciliation, data query resolution, and resolution of outstanding action items.
• Ensures internal and study-related trainings are completed per Lotus and/or study timelines.
• Performs pre- and post-visit follow-up, including compliance with timelines for Confirmation Letters, Follow-up Letters, and Monitoring Visit Reports.
• Collaborates with the CRA Line Manager to support mentoring, training, and assessment of CRAs and junior staff as applicable.
• Performs other related duties as requested.

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.
• Ability and willingness to travel up to 100% of the time (land and air), both domestically.

Skills

• 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 and organizational skills.
• Exceptional attention to detail.
• Ability to interact effectively within and across team environments.
• Exceptional ability to exercise professional judgment and determine appropriate action for problems of varying complexity.
• Strong ability to work effectively and efficiently while 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

• Regularly reaches with hands and arms.
• Periodically lifts and/or carries up to 10 pounds.
• Occasionally stoops, bends, kneels, and crouches; pushes/pulls filled wheeled carts.
• Requires close vision, color vision, and ability to adjust focus.

Work Environment

• May work in a clinical research site environment with moderate noise levels, a travel environment with moderate to high noise levels, or a home office environment with largely controlled noise levels.
• Subject to many interruptions and pressure due to deadline requirements.
• Handles multiple tasks simultaneously while performing assigned duties.

Safety Requirements

• Must 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.
• Must wear appropriate safety/protective equipment.
• Must practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time.