Clinical Research Associate I
2 weeks ago
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Conduct Source Document Review of appropriate site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Reconcile contents of the ISF with the Trial Master File (TMF).
- Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Support subject/patient recruitment, retention and awareness strategies.
- Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Understand project scope, budgets, and timelines for own and others' activities in the clinical team; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
- Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepare for and attend Investigator Meetings and/or sponsor face to face meetings.
- Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provide guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs.
- May perform training and sign off visits for junior CRA staff, as assigned.
- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
- For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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