Clinical Development Academy: Clinical Research Manager (Miami, FL)

The clinical development academy hires groups of colleagues into tracks aligned to their background and career goals- delivering best in class training to prepare them for a successful career in clinical research at Thermo Fisher.  We are currently hiring for our mid-career track, uniquely designed for experienced clinicians interested in transitioning into a career in the contract research organization (CRO) industry.  Successful applicants will join a cohort of their peers in a training program that prepares them to move into a Clinical Research Manager role.  At the end of the program, successful academy members will transition to full time role working at research sites. 

These positions will be based on a few locations:  Atlanta, GA; Chicago, IL; Cincinnati, OH; San Antonio, TX; Miami, FL

If you are an experienced clinician interested in transitioning your career into the CRO industry, this is an opportunity for you. 

Manages aspects of clinical trials ensuring patient safety and cooperation during the study process.  Ensures adherence to client requirements and specifications.

• Reviews inclusion/exclusion criteria with patients to ensure eligibility to participate in study. Interacts with Primary Investigator for inclusion/exclusion review of patient data
• Reviews and witnesses the consenting process for subjects. Prepares study-specific documents for pre-study screening. Maintains screening/enrollment log and required documentation such as screening failures and phone communications to patients and/or clients
• Ensures the safety of patients by monitoring AEs, if any, and communicating potentially serious findings to physician
• Performs delegated study-related procedures according to the schedule of events and protocol specifications (i.e., check-ins, administration of drug, blood draws, ECGs, vital signs, etc.)
• Maintains high quality standards in data, including drug accountability, concomitant medications, regulatory approvals, while minimizing protocol deviations
• Monitors staff to assure adherence to Good Clinical Practices, ICH, FDA, and OSHA guidelines

The academy program offers:

• Competitive pay during training practicing/honing role-specific tasks  
• An opportunity for mid-career talent to transition skill sets into a new and exciting career  
• A focus the learner’s needs with on-the-job, colleague-led, and instructor/formal training 
• Cohort of colleagues starting and learning together in a collaborative and organized environment, resulting in a strong network of future colleagues
• Training materials tailored to role-specific objectives set academy graduates up for success in a variety of future roles
• Regular training sessions around professional development, spotlight on business units across the organization, and skill-specific trainings to provide a well-rounded experience
• Experienced people managers focused on creating a supportive and positive experience for all new hires

Qualifications 

Education and Experience:

• Registered Nursing certification or equivalent and relevant formal academic/vocational training; active license in applicable state.
• Comprehensive experience as a clinician in a healthcare environment (comparable to at least 2 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.
• Program or people manager experience preferred.
• Valid driver's license where applicable.

Knowledge, Skills and Abilities:

• Effective oral and written communication skills, with the ability to communicate effectively across various stakeholders
• Excellent interpersonal skills, including patient centricity
• Strong attention to detail and quality of documentation
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving; enthusiasm for learning and asking questions
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Willingness and ability to administer investigational drugs including oral, intravenous, topical, or other approved method of dosing
• Willingness and ability to learn and perform a variety of technical procedures such as drawing blood, processing and harvesting lab specimens, taking vital signs, performing ECGs, etc.
• Ability to work in a team environment or independently, under direction, as required
• Good organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• May require travel

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours. 
• Able to lift and move objects up to 25 pounds 
• Able to work in non-traditional work environments. 
• Able to use and learn standard office equipment and technology with proficiency. 
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.