Freelance Senior/Clinical Research Associate

RESPONSIBILITIES

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

Provide monitoring visits and site management for a variety of protocols and sites within the Oncology therapeutic areas.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

May provide assistance to less experienced clinical staff.

All responsibilities are essential to job functions unless noted as non-essential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Good therapeutic and protocol knowledge as provided in company training

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

Good written and verbal communication skills including good command of English language

Good organizational and problem-solving skills

Effective time management skills

Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in a health care or other scientific discipline or educational equivalent, and successful completion of a CRA Trainee Program or 3months + of on-site monitoring experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Frequent travel to sites, primarily domestic, may include international travel

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.