Essential Function
To support the Clinical Research Associate (CRA) team and / or Clinical Leads according to Task Order Matrix throughout the complete conduct of the study by documenting information concerning the progress of clinical trials such that it is always complete, up to date and available to team members, sponsors and auditors. To help communicate and follow up on actions between clients, sites, team members and other members of the project team and to be viewed by the CRAs and CLs as an important source of project information and assistance.

Parameters:

Comply with Company policies, SOPs and Regulatory guidelines.
Key Accountabilities when supporting CRAs
'Receive, track and inventory documents for central files. Ensure that documents required by team members are accessible. Obtain any missing/incomplete data from investigators in conjunction with CRAs.
'Ensure accuracy of coded documents for central files, perform document scanning when applicable.

'Produce reliable up to date reports of patient/study status through maintaining CTMS or client equivalent to ensure that clinical data input is up to date, accurate and complete.
'Ensure the complete documentation and timely arrival of clinical supplies and study drugs for site visits, in conjunction with CRAs.
'Assist CRAs on-site as needed.
'Ensure CRF pages are being processed, tracked and forwarded to Data Management on time.
'Assist with (telephone) query resolution as needed.
'Ensure the timely and accurate investigator payments, in conjunction with CRAs.
'Participate in project meetings (taking minutes if appropriate), replace CRAs on project team calls when necessary.
'Have up to date knowledge on study procedures and study related materials.
'Ensure work adheres to Good Clinical Practices, applicable regulatory and legal requirements, and PAREXEL Standard Operating Procedures (or clients', according to exhibit) proactively flagging any issues to the appropriate CRA.
'Serve as a resource for the project team or Clinical team, depending on workload can be delegated to other project related tasks (e.g. set-up activities, other).
'Contribute to the smooth running of the department and departmental activities e.g. arranging meetings and travel.

Key Accountabilities when supporting Clinical Leads

'Provide support to Clinical Lead and to study team.
'Responsible for completeness, quality, and accessibility of Central Files.
'Supervise receipt, tracking, and archiving of documents for Central Files.
'Responsible for accuracy of coded documents for central files.
'Provide Clinical Lead and the team with detailed information on study procedures and study related materials.
'Ensure adherence to Good Clinical Practice, applicable regulatory and legal.
requirements as well as PAREXEL's or client's SOPs.
'Development of Central File Maintenance Plan, CTMS-Data Entry Guidelines and other study specific plans, forms and templates in close cooperation with Clinical Lead.
'Responsible for up to date reports of study status in CTMS or client equivalent.
'Support Clinical Lead in the set-up and maintenance of systems e.g. PMED.
'Responsible for the timely arrival of clinical supplies and study drugs at the sites.
'Responsible for timely and accurate investigator payments.
'Organise project meetings and taking of minutes.
'Ensure the smooth operation of the department and departmental activities e.g. supervising arrangement of meetings andRecommend process improvements for Clinical Research Assistant tasks.
'Proactively flag any project related issues.

Skills

'Excellent interpersonal, verbal and written communication skills.
'Ability to communicate directly with CRAs/CLs in an international environment.
'Ability to communicate directly with Sponsor / other vendors.
'A flexible attitude with respect to work assignments, new learning and travel.
'Demonstrated ability to manage multiple and varied tasks with positive attitude, prioritize workload with attention to detail and within agreed timescales.
'Willingness to work in a matrix environment and to value the importance of teamwork.
'Demonstrated ability to work independently and use initiative to complete tasks.
'IT literate ' Experience with Microsoft based applications and general knowledge of PC functions, especially knowledge of Excel.

Experience:
Education
'Minimum education ' ideally degree in life science, Pharmacy Graduate, nursing qualification or other related background.

Language Skills
'Competent in oral and written English.

Minimum Relevant Work Experience: 6 Months & above
'Previous involvement as CRA assistant in an international study or similar experience in office management of international trial would be preferred