Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.
You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.
Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-
deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
The Clinical Research Associate II (CRAII) will complete project activities associated with monitoring functions of Phase I-
IV clinical research studies whilst continuing to develop a solid understanding of the drug development process. Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-
GCP, and all applicable regulatory requirements. Essential Functions :
Plans and conducts study initiation visits for investigator sites. Applies planning techniques for monitoring visits to ensure efficient and effective monitoring.
Plans and conducts study close-out visits for investigator sites. Manages and prioritizes workload effectively.
Maintains awareness of key study performance indicators for own sites. Supports subject recruitment and retention strategies.
Updates study and subject status information. Documents and tracks the resolution of all outstanding site-specific protocol-
related issues from contact to contact and anticipates / identifies potential issues and implements corrective actions. Seeks guidance to resolve complex issues.
Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, bio sample management and subject reported outcomes instruments as applicable.
Follows standard process for documentation of site contacts (visits, phone, email etc.).
Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject’s safety and clinical data integrity at an investigator site such as protocol deviation / violations and pharmacovigilance issues.
Verifies clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Performs these tasks routinely and independently, seeking guidance as needed.
Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.
Reconciles contents of the ISF with the trial master file (TMF). Ensures investigator site is aware of requirement of archiving essential documents in accordance with the local guidelines and regulations.
Verifies site compliance with requirements for electronic data capture. Performs these tasks routinely and independently seeking guidance as needed.
Seeks guidance to resolve more complex tasks. Uses the appropriate mode of communication in relaying information. Participates in global conference calls and meetings to review progress of ongoing clinical trials.
Other Responsibilities :
BA / BS degree in science / health care field or nursing degree or equivalent combined education and experience. Moderate experience as a CRA in directly relatable site management, or clinical site conduct experience.
PSSV, SIV, IMV, COV. Experience of Observation / Training visit on all types of visits. Competent in independent drug accountability.
Competent in independent investigator site file review. Demonstrates understanding of all Essential Documents and their collection and maintenance.
Off-site experience : familiarity with basic category of Clinical Monitoring Associate tasks. Ability to understand / guide site staff to execute on clinical protocols.
Understanding of local regulatory, safety, and GCP. Demonstrate proficiency in navigation within : CTMS systems, Data Platforms for projects, Microsoft Suite : Excel, Word, Power Point, Outlook, Site EMR systems.
Model professional communication in both written and verbal interactions. Demonstrate sufficient time management to achieve required deliverables.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.#LI-VF1