Join as a Senior Clinical Research Associate
As part of their global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You’ll Do:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved, and that data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial closeout and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company, and the internal project team through written, oral, and/or electronic contacts.
- Responds to company, client, and applicable regulatory requirements/audits/inspections.
- Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life sciences-related field, a Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to years as a clinical research monitor) or completion of a recognized Drug Development Fellowship.
- Valid driver's license where applicable.
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents
- Well-developed critical thinking skills, including a critical mindset, in-depth investigation for appropriate root cause analysis, and problem-solving
- Ability to manage Risk-Based Monitoring concepts and processes
- Strong oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through active listening skills, attention to detail, and the ability to perceive underlying customer issues
- Strong organizational and time management skills
- Effective interpersonal skills
- High attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work effectively in a team environment or independently as required
- Solid computer skills, including strong knowledge of Microsoft Office and the ability to learn role-specific software
- Excellent English language, grammar, and presentation skills
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
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