Senior Clinical Research Associate

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Senior Clinical Research Associate to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. In this role you will be responsible for: managing clinical activities at study sites conducting studies for the Company group, as well as, fostering strong, productive relationships with colleagues within the Company Group; managing clinical study activities for multiple sites in single or several clinical projects; oversees performance of appointed study sites, conducting company initiated clinical studies; the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

Clinical Study Site Management Tasks

• Ensures that all work related activities, and decisions embody the Company Credo Values.

• Verify safety and well-being of study subjects are maintained for assigned study sites.

• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.

• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.

• Accountable for study site performance, and providing high quality data according to overall project timeline.

• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.

• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.

• Responsible for supporting patient recruitment and retention activities.

• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.

• Assists with internal communication of important clinical data and events.

• Support organization of Investigator and other study training meetings, if required.

• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.

• Understand business value of clinical projects and balances overall business objectives and functional needs.

• May be involved in other tasks to support Clinical Operations and Operating Company as needed.

• Support the implementation of new clinical systems/processes.

• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks

• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

• May be asked to provide additional support to Clinical Operations staff, as needed.

Education and Experience:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

• Typically requires Bachelor’s degree with at least 4 years of relevant experience; Masters or PhD/MD/PharmD with at least 2 year of relevant experience.

• Previous clinical research experience required.

• Previous medical device monitoring or equivalent experience required.

• Good understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.

• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Clinical/medical background – a plus.

• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point).

Demonstrated competencies in the following areas are required:

• Leadership.

• Written and verbal communications.

• Presentation and influencing.

• Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).

• Ability to travel up to 80% of time.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Clinical Research Associate, Clinical Trial, Clinical Study Site Management, Monitoring Visits, ICH-GCP, Regulatory, Ms Office, Medical Devices, Contract Research Organisation, CRO.

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