Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.
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Clinical Research Associate Job Description Template
We are looking for an organized, flexible Clinical Research Associate to oversee clinical trials. The Clinical Research Associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The Clinical Research Associate will manage multiple aspects of subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.
To be successful in this role, you should be able to recognize logistical problems, and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask and be able to collaborate with various role players.
Clinical Research Associate Responsibilities:
- Creating and writing trial protocols, and presenting these to steering committee.
- Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.
- Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
- Liaise with ethics committee regarding rights, safety and well-being of trial subjects.
- Ordering, tracking, and managing IP and trial materials.
- Overseeing and documenting IP dispensing, inventory and reconciliation.
- Protecting subjects’ confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol.
- Conducting regular site visits, coordinating project meetings and writing visit reports.
- Implementing action plans for sites not meeting expectations.
- Liaising with regulatory authorities.
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Other tasks and responsibilities as needed.
Clinical Research Associate Requirements:
- Bachelor’s degree in Biological Science or a related field.
- 2+ years experience as a Clinical Research Associate.
- Knowledge of pharmaceutical industry, terminology and practices.
- Knowledge of FDA regulations and their practical implementation.
- Strong verbal and written communication skills.
- Proficient computer skills.
- Proficient with Microsoft Office Word, Excel and Power Point.
- Ability to manage and prioritize workload effectively.
- Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
- Valid driver’s license, proficient driving skills, own reliable transport and up-to-date car insurance.