Site Management Associate
hace 1 mes
We are seeking a highly skilled Site Management Associate to join our team at Syneos Health, a leading biopharmaceutical solutions organization. As a Site Management Associate, you will play a crucial role in the successful execution of clinical trials.
**Job Overview:**
The Site Management Associate will be responsible for site qualification, site initiation, interim monitoring, site management activities, and close-out visits. You will work closely with project teams to ensure regulatory compliance, ICH-GCP, and Good Pharmacoepidemiological Practices (GPP). Your expertise in clinical data review and capture will be invaluable in driving query resolution to closure within agreed timelines.
**Key Responsibilities:**
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
- Assess site processes and conduct source document reviews of appropriate site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete, applying query resolution techniques remotely and on-site as necessary.
- Utilize available hardware and software to support the effective conduct of the clinical project data review and capture.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconciling contents with the Trial Master File (TMF).
**Requirements and Qualifications:**
To be successful in this role, you will need:
- A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Excellent communication and interpersonal skills, with the ability to work effectively with project teams and site personnel.
- Strong analytical and problem-solving skills, with the ability to quickly adapt to changing priorities.
- Knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
**Why Join Us:**
Syneos Health offers a dynamic and supportive work environment, with opportunities for career growth and development. Our team is passionate about delivering exceptional results and making a positive impact on patients' lives. We offer a competitive salary range of $70,000-$100,000 per year, depending on experience, as well as benefits and perks that include health insurance, 401(k) matching, and paid time off. If you're a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply today
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