Tax Analyst, South Africa

CRA II (6 month contract) homebased South Africa

Clinical Research Associate II

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. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself.

Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with.

Job Responsibilities

1. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and / or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
2. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates / escalates serious issues to the project team and develops action plans.
3. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
4. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient, as required / appropriate.
5. Demonstrates diligence in protecting the confidentiality of each subject / patient.
6. Assesses 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.
7. Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required 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.
8. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture, verifies site compliance with electronic data capture requirements.
9. May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
10. Verifies the IP has been dispensed and administered to subjects / patients according to the protocol.
11. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
12. Reconciles contents of the ISF with the Trial Master File (TMF).
13. Documents 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.
14. Supports subject / patient recruitment, retention, and awareness strategies.
15. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables, and timelines are met.
16. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
17. Prepares for and attends Investigator Meetings and / or sponsor face-to-face meetings.
18. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
19. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes; completes assigned training as required.
20. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.

Qualifications

1. Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
2. Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements.
3. Must demonstrate good computer skills and be able to embrace new technologies.
4. Excellent communication, presentation, and interpersonal skills.
5. Ability to manage required travel of up to 75% on a regular basis.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Seniority level: Entry level

Employment type: Full-time

Job function: Research and Science

Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services