CLINICAL RESEARCH ASSOCIATES / CRA

LOCATION: Croatia, Czech Republic, Dubai, Greece, Israel, Italy, Saudi Arabia, Serbia, Slovakia, United Kingdom (Glasgow Office-Based)

Working as a CRA for ClinTec you will be involved in some of the most prestigious drug development projects for a number of leading global pharmaceutical companies with the opportunity to develop progress and travel globally. This is a perfect role for Clinical Research Associate who understands the drug development process, has significant experience within CRA role and is willing to travel as required.

ACCOUNTABILITIES:

Identify, select, initiate and close-out appropriate investigational sites for clinical studies.

Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.

Site management to ensure proper adherence to protocol, source data verification and assess CRF entries as well as ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.

Carry out drug formulation administration procedures and documentation records and ensure adequacy of drug shipment and drug accountability.

Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required. Provide support to the Project Manager / Country Manager with ad-hoc tasks as required.

EVALUATION CRITERIA:

Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline.

Significant experience in performing a Clinical Research Associate role within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company.

Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.

Ability to contribute to the development of clinical trial related documents and materials.

Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.

Good communication and presentation skills including the ability to present complex information to both clinical and non-clinical disciplines.

Fluency in English language (both written and spoken).

Experience across a wide range of clinical indications / therapeutic areas would be beneficial.

Ability and experience to work with an electronic case report form (eCRF) is desirable.

SENIOR CLINICAL PROJECT MANAGER / SPM

LOCATION: United Kingdom (Glasgow Office-Based)

BENEFITS:
Competitive salary, training & development

The Senior Project Manager will be responsible for leading for one or more clinical trials simultaneously and be responsible for the initiation, conduct and reporting of clinical trials or programmes.The Senior Project Manager will ensure by co-ordination of project team activities that these projects are completed on or below budget, on or ahead of time and on target, according to the requirements of the contract with the Sponsor and ensure that project activities are executed according to the quality standards defined by appropriate procedures and by ICH GCP.

ACCOUNTABILITIES:

Supervise and evaluate the project management team and conduct of clinical trials to ensure the accomplishment of established goals and objectives.

Manage and coordinate project team activities to ensure consistently high performance across the ClinTec project portfolio to the satisfaction of the client(s).

Contribute to the development of new systems to facilitate management of projects and department operations.

Monitor and review the clinical studies in terms of financial progress, business metrics, KPI’s and compare to milestones delivered.

Provide timely input into monthly internal programme management project status reviews.

Develop project schedules of tasks with input of project team members; identify responsible parties, staffing needs, and timeframe for completion of project with list of deliverables, plan timeline in concert with client commitments.

Identify impending obstacles to the successful completion of the project, analyse information and develop innovative solutions to challenges.

Serve as a mentor to Project Managers including the facilitation of their training and orientation and as a resource for administrative and project related issues.

Participate as required, in proposal development, business development, and client presentations and be available to present department responsibilities and functions to potential clients.

Participate in development and implementation of department training programmes where required.

EVALUATION CRITERIA:

Bachelor’s degree, equivalent of higher qualification in a relevant life sciences discipline.

Significant track record within clinical project management.

Excellent knowledge of the pharmaceutical product development process and broad therapeutic exposure.

Clear understanding of contracts and scope of work.

Ability to demonstrate strong commercial business acumen.

Ability to work to strict operational deadlines and manages conflicting priorities accordingly.

Excellent communication skills including the ability to interact and manage relationships with international colleagues and clients orally and in writing.

High level of IT literacy including use of Internet, email and Microsoft Office suite of packages.

Willingness and ability to travel internationally on a regular basis.

Eligibility to live and work in the United Kingdom.

Formal Project Management Training / Accreditation.

Fluency in second language.

QUALITY ASSURANCE AUDITOR / QA

LOCATION:
Worldwide

BENEFITS:
Competitive salary, training & development

In this new position, the Auditor will work closely with the Head of Quality in providing clinical quality assurance support for all ClinTec operations.  The Auditor will be responsible for planning and undertaking GCP compliance audits, vendor audits, system and documentation audits and providing support during regulatory inspections and sponsor audits.  Other key accountabilities are providing quality management system, providing updates on quality activates and providing advice on approaches to meet current GCP and regulatory requirements.  This is a key role in an expanding organization with a dedication and commitment to qualify clinical research. The successful candidate will be an experienced GCP auditor with a clear appreciation of the regulations governing clinical trials.  The ability to multi-task, troubleshoot, problem solve, research, and make sound decisions based on scientific evidence and regulatory requirements is a must.

ACCOUNTABILITIES:

Undertake GCP compliance audits in all areas of clinical operations.

Conduct vendor audits and qualification assessments.

Plan, undertake and document study audits to verify the integrity of the data and determine whether studies are undertaken in compliance with GCP, legislation, industry guidelines, protocol and procedures.

Assist in preparation and facilitation of sponsor audits and GCP regulatory inspections.

Undertake system audits and document specific audits to determine whether procedures and systems are adequate, relevant to current operational practices and compliant with SOPs.

Identify any procedures that are not consistent with GCP, regulatory requirements or applicable guidelines.

EVALUATION CRITERIA:

Bachelor’s degree, equivalent or higher qualification within a relevant life sciences discipline.

Proven knowledge and experience in GCP auditing Proficiency in ICH GCP Guidelines and regulatory requirements for the conduct of clinical trials.

Understanding of the drug development process.

SENIOR CLINICAL RESEARCH ASSOCIATE / SCRA

LOCATION:  New York, New Jersey, Boston, Kansas, San Francisco, Washington

BENEFITS: Competitive salary, training & development

Working as a SCRA for ClinTec you will be involved in some of the most prestigious drug development projects for a number of leading global pharmaceutical companies with the opportunity to develop progress and travel globally. This is a perfect role for Clinical Research Associate who understands the drug development process, has significant experience within CRA role and is willing to travel as required.

ACCOUNTABILITIES:

Identify, select, initiate and close-out appropriate investigational sites for clinical studies.

Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.

Site management to ensure proper adherence to protocol, source data verification and assess CRF entries as well as ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.

Carry out drug formulation administration procedures and documentation records and ensure adequacy of drug shipment and drug accountability.

Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required. Provide support to the Project Manager / Country Manager with ad-hoc tasks as required.

EVALUATION CRITERIA:

Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline.

Significant experience in performing a Clinical Research Associate role within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company.

Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.

Ability to contribute to the development of clinical trial related documents and materials.

Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.

Good communication and presentation skills including the ability to present complex information to both clinical and non-clinical disciplines.

Fluency in English language (both written and spoken).

Experience across a wide range of clinical indications / therapeutic areas would be beneficial.

Ability and experience to work with an electronic case report form (eCRF) is desirable.

IF YOU ARE RELEVANT TO ANY OF THE ABOVE VACANCIES, PLEASE EMAIL YOUR CV TO CAREERS@CLINTEC.COM. THANK YOU.