EMD Serono, Inc. is proud to belong to the oldest pharmaceutical and chemical company in the world. With a history spanning more than 300 years, our parent company, Merck KGaA, still operates successfully in both sectors. We are known in the United States as EMD, a name that stands for Emmanuel Merck, Darmstadt, heralding back to our roots in Germany.
Post: Senior Clinical Research Associate
Purpose of the Role
To oversee the conduct of clinical trials at assigned trial sites, within the agreed time?scale, by regular monitoring. Once responsibility has been assigned, the CRA is the primary contact between the trial site and Sponsor. All tasks are conducted in accordance with applicable Policies, Standard Operating Procedures (SOP), Work Instructions (WIs) and conventions, as well as current ICH Good Clinical Practice (ICH GCP) and applicable local regulations.
INTERNALLY: All members of Clinical Monitoring team, All members of Clinical Trial Management team and other members of Development and Clinical Operations.
Other Departments: - Local affiliate(s)/ Medical Affairs, Local Financial Controller, Legal.
EXTERNALLY: CROs, Vendors and suppliers as appropriate
Key Tasks & Responsibilities
To contribute to the development of clinical trial related documents including but not limited to protocols, case report forms, informed consents, conventions, data query plans etc, with the responsible Clinical Monitoring Leader and Clinical Trial Leader.
To identify/confirm, on request from Clinical Monitoring Management, suitably qualified trial sites within a specified geographical area. To make initial contacts, conduct evaluation visits and subsequently to establish relationships with selected trial sites in order to ensure study targets for recruitment, quality and costs are implemented.
To assist in obtaining regulatory and ethics approvals, when requested.
To monitor all stages, from evaluation to close-out, of the conduct of clinical trials at assigned trial sites, write reports within the timeframe agreed at study start, maintain required documentation in the investigator file and provide required documentation for the Trial Master File. To ensure the trial site complies with the study protocol, GCP and applicable regulatory requirements.
To control the integrity of the data produced by trial sites through review of case report forms, source documents/medical and pharmacy records. To ensure the above is conducted in accordance with the agreed study timelines, with tracking logs effectively maintained.
To liaise with the relevant drug safety department and the Medical Responsible in the management of serious adverse events and SAEs, and assure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOP), Work Instructions and conventions, as well as current Good Clinical Practice (GCP) and applicable local regulations.
To provide trial site updates to the CM Leader, Clinical Trial Leader and Medical Responsible within the timeframe agreed for the study and in accordance with the nature of the communication (critical versus routine).
To assist in negotiating grants and contracts, and in budget forecasting and payments.
To manage investigational medicinal product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates, and assist in investigational medicinal product forecasting in accordance with study agreements.
To assist trial sites to meet project timelines and budgets, and proactively identify to CM Management and Clinical Trial Leader when alternative/corrective action is necessary.
To assist in the preparation for trial site audits and inspections, and to participate in the audits and inspections and in responding to any issues identified within the timeframe specified.
To maintain/develop a good level of scientific knowledge within Sponsors therapeutic areas.
To maintain and develop PC skills required to work efficiently.
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To liaise with other CRAs to ensure harmony of standards and procedures and to contribute to the review (and drafting) of existing and new SOPs, Work Instructions and study specific conventions, when requested. Participating in working groups if needed.
To promote and maintain effective communication with all interfaces and represent CM in interdepartmental process improvement initiatives (see above).
To work independently with minimal supervision giving rigorous attention to administrative details. Attending CRA meetings and trainings as requested.
To undertake the role of CM Leader upon request. May involve assisting and overseeing other CRAs, CTCs and CTDCs if assigned.
To gain and/or demonstrate proficiency in electronic data capture.
To coach less experienced colleagues when appropriate.
Other additional responsibilities may be assigned, as appropriate.
Education & Languages
Biological science/pharmacy/nursing degree or Nursing qualification.
Minimum 5 years CRA experience or combination of CRA + other relevant experience (e.g. regulatory, clinical QA, pharmaceutical sales, study site coordinator).
Proven track record demonstrating thorough knowledge of ICH GCP and applicable local regulations (e.g. EU/ FDA regulatory requirements for drugs or biologics).
Experience in relevant therapeutic areas.
Experience of internal audit.
Involvement in protocol, CRF, other trial related document development.
Understanding of drug development process.
Excellent oral and written communication skills in English.
Professional Skills & Experience
Phase I to IV experience.
Experience of regulatory inspection.
Evidence of creative problem-solving skills.
Personal Skills & Competencies
Proficient PC skills: Word, Excel, PowerPoint, email.
Excellent organizational ability and flexibility.
Strong interpersonal skills.
Highly self-motivated and proactive, with a keen attention to detail.
Excellent time-management skills.
Goal orientated, able to effectively prioritize and execute tasks in a high-pressure environment.
Ability to be a team player.
Ability to work from home.
Be willing and able to travel (a commitment of up to 70% travel may be required).
Be willing to aid CM in cross-regional resource roles where mutually convenient.
Experience: Min. 5 Years
Education: B.Pharm, M.Pharm, BS, MS - Biological Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
End Date: 29th Nov., 2011
Job ID: 1103019
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