Tissue Solutions (www.tissue-solutions.com) is a leading provider of human bio-specimens for researchers worldwide to help our clients develop and test new therapies. Incorporated in 2007, we are ISO 9001:2015 certified and provide the pharmaceutical and biotech industries with high quality sample sets from a global network of more than 150 sources. We are an approved research tissue bank. Samples include diseased and normal tissue in fresh, frozen, and FFPE formats. We guarantee samples with the highest possible ethical compliance, offering reliable and efficient sourcing of biological material globally.
This is a new position for an experienced Clinical Research Associate or Project Manager who will be responsible for the development of new capabilities in Tissue Solutions’ sourcing capacity in the UK, including recruitment and management of all tissue collection sites under our UK ethical approvals.
Main duties and responsibilities:
This role would suit an entrepreneurial individual with clinical research or project management expertise and a background in life sciences or medicine/nursing. A good fit would be someone who has experience of Good Clinical Practice, preparation of ethics applications for clinical trials and site recruitment. You will need to have a commercial outlook and experience working in a CRO is preferred. Also a good understanding of the regulatory requirements for human tissue and blood collection, ideally for therapeutic use would be beneficial. Experience in the selection of Principal Investigators and developing strong relationships would be advantageous.
You need to be a highly motivated self-starter, with the ability to think innovatively and work independently. Your main duties and responsibilities are
- Expansion of our tissue acquisition service through proactively seeking and establishing new collection sites
- Recruiting PIs and managing initiation of collection sites.
- Site visits, audits and training of collection sites
- Ensuring regulatory compliance
- Preparing ethics applications and study specific documents
- Clinical protocol development
- Manage sample collections, liaising with doctors, consultants at collection sites
- Grow and manage volunteer donor database across a range of diseased areas and control normal healthy volunteers
- Establish relationships with disease specific support groups and clinical groups.
Qualifications and Experience
- Degree in Life Sciences
- Track record in starting new teams and services, with the ability to drive projects to conclusion
- Proficient in Project Management and able to drive progress across multiple stakeholders
- Interested in building sustainable processes and relationships with the ability to build trust quickly and motivate
- Excellent customer service
- Able to work quickly and accurately, taking significant initiative
- Strong relationship and networking skills
- Knowledge of clinical research process and medical terminology
- Strong written and verbal communication skills to manage study personnel at research and clinical institutions
- Proven experience in monitoring and/or coordinating clinical trials preferred; experience in a clinical setting a plus
- Understand current GCP/ICH guidelines applicable to the conduct of clinical research
- Ability to work effectively under pressure with strong organizational and interpersonal skills
- The drive and commitment to achieve project goals
If you would like to apply then please send your covering letter, CV along with details of salary expectations to firstname.lastname@example.org.