Senior Clinical Research Associate
An international pharmaceutical company is currently recruiting for a Senior Clinical Research Associate to join their office in Germany. The organisation is a specialised service company that supports next generation approaches to drug development and commercialisations by assisting pharmaceutical and life sciences companies as they develop new products. Based in the company's German office, this is an exciting opportunity to work with an innovative and dynamic firm.
- Serves as a member of the project team with the goal to contribute towards efficient management of trials.
- Assists the team managers in the preparation and review of protocols and other study documentation.
- Designs and develops CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).
- Oversees all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Manages site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the project manager.
- Negotiates study budgets and assists with the execution of investigator contracts.
- Conducts all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP and Precision Oncology's SOPs.
- Prepares accurate and timely visit reports from all monitoring visits.
- Communicates effectively with both site personnel and Precision Oncology management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
- Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision Oncology's high quality and ethical image.
- Maintains study tracking, in accordance with the demands of the study.
- Performs data management activities, including in-house CRF review, query resolution, and resolves data discrepancies, dependent upon the study/sponsor arrangement.
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process and when required, may write narratives and follow-up on SAEs as needed
- Travels as necessary according to project needs.
- Functions as a mentor, assisting with the training and developing of new employees and junior monitors.
- Assists with the development of SOPs
- Assists with review of clinical study reports.
- Conducts feasibility work when requested.
- Interacts with client, participates in proposal activities, including development and client presentations.
- Initiates payment requests for investigators.
- Assumes project management responsibility as needed.
Skills and Requirements:
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
- 3 years or more as a CRA either in CRO or Pharmaceutical industry.
- The CRA III or Sr. CRA is a further continuation along the development path for clinical operations professionals. Responsibilities will be dependent upon the type and timing of the program to which the Sr. CRA is assigned.
- Candidates for this position are expected to be able to manage appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. An increased focus on training and mentoring junior staff members may also be expected from the Sr. CRA.
- 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 Iskandaraniat +44 203 854 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.
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