Senior Clinical Research Associate
A global contract research organisation have an exciting job opening for a Senior Clinical Research Associate to be home-based. The company specialises in research into pharmaceuticals, healthcare and nutrition and offer flexible conditions and excellent career development opportunities.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conducting of pre-study and initiation visits; liaising with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- Ensuring the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensuring the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensuring the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
- Ensuring the resources of the Sponsor and company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to company travel policy.
- Preparing accurate and timely trip reports.
- Managing small projects under the direction of a Project Manager/Director as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
- Reviewing the progress of projects and initiate appropriate actions to achieve target objectives.
- Organising and make presentations at Investigator Meetings.
- Reporting, writing narratives and following-up on serious adverse experiences.
- Participating in the development of protocols and Case Report Forms as assigned.
- Participating in writing clinical trial reports as assigned.
- Interacting with internal workgroups to evaluate needs, resources and timelines
- Acting as the contact for clinical trial supplies and other suppliers (vendors) as assigned.
- Responsible for all aspects of registry management as prescribed in the project plans.
- Undertaking feasibility work when requested.
- Recruiting potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organisation of meetings and other tasks as instructed by supervisor as assigned.
- Negotiating study budgets with potential investigators and assist the company legal department with statements of agreements as assigned.
- Completing the process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently performing CRF review; query generation and resolution against established data review guidelines on company or client data management systems as assigned by management.
- Assisting with training, mentoring and development of new employees, e.g. co-monitoring.
- Co-ordinating designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
- Performing other duties as assigned by management.
Skills and Requirements:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered.
- Advanced site monitoring skills.
- Advanced study site management skills.
- Advanced registry administration skills.
- Ability to work with minimal supervision.
- Works efficiently and effectively in a matrix environment.
- Valid Driver's License.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani at 0203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.