Clinical Document Agent (On Site - MIAMI, FL)

Description

Clinical Document Agent

The clinical document agent is responsible for creating the documentation forms for clinical projects, drafting patient files and converting raw data into electronic format while ensuring that pre-established procedures and processes are followed. Extensive experience and high level knowledge of Microsoft Excel is required for this role, as well as fluent English (written and spoken).

Job responsibilities

* Carry out the full spectrum of activities related to creating subject files, which include tasks such as reviewing templates, ensuring that timelines are adhered to and correcting mistake before transcription and following-up on client comments.

* Generate electronic documentation forms for the clinic.

* Suggest and order subject meals for the length of a study and perform the necessary follow-up.

* Digitalizes the raw data from studies transferred by the Clinical Study Manager.

* Calculate the final blood volumes for each subject per study and ensure that each subject participating in a study has the correct dates for their wash out period.

* Perform peer review for the work performed by the team.

* Help to resolve problems related to the work being performed.

* Provide training to new team members

* Contact the various collaborators both within and outside of the department in order to obtain the documents necessary for meeting timeframes.

May be assigned other clinical tasks

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.

Discover what our 29,000 employees, across 110 countries already know:
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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Qualifications

What we're looking for

Position in Canada

* High School Diploma

Position in US

* Associates degree or High School diploma

Relative alternate certification may be considered acceptable.

* Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel

* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

* Experience in regulatory context will be considered an asset

Candidate who does not possess the required training and/or experience may be considered under different criteria.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

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.

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, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.