JOB SUMMARY: We are seeking a motivated and enthusiastic Intern to join our dynamic Clinical
Research team. This apprenticeship will provide hands-on experience in various Clinical Research
functions including screening subjects recruiting subjects research visits study activities and
administrative support. The ideal candidate is eager to learn detail-oriented and passionate about
building a career in Clinical Research.
SPECIFIC JOB DUTIES AND RESPONSIBILITIES:
Didactics:
Interns are expected to:
1. Attend all didactic sessions and actively participate in discussions.
2. Complete monthly assessments and obtain passing scores.
3. Take the final exam and achieve a passing grade.
Hands-on Training:
By the end of the training period interns are expected to demonstrate proficiency in the following
areas:
1. Participate in patient screening informed consent discussions participant assessments
scheduling of procedures and retention efforts. Notify the research team of relevant study
activities.
2. Complete case report forms (CRFs) accurately and respond to sponsor queries in a timely
manner.
3. Participate in subject visits and ensure that all subject questionnaires are complete legible and
accurate in accordance with ALCOA principles (Attributable Legible Contemporaneous
Original and Accurate).
4. Conduct follow-up communications with study subjects regarding study objectives and
document all interactions appropriately.
5. Maintain complete and accurate study records and file documents in accordance with protocol
and system requirements.
6. Understand and comply with regulatory guidelines and institutional policies relevant to each
study and associated regulatory agencies.
7. Assist in managing study supplies including documentation of receipt tracking expiration dates
and reviewing sponsor-provided study manuals.
8. Update team tracking reports regularly provide database-generated reports when requested
and support the execution of project tasks as assigned.
9. Participate in the collection processing labeling storage and shipment of specimens following
protocol-specific requirements.
10. Prepare descriptive reports summarizing research study progress and outcomes utilizing
appropriate study systems and data records.
11. Attend meetings with team members investigators and sponsors as required.
12. Maintain a high level of organization attention to detail and efficiency in a fast-paced research
environment.
13. Keep training records current and ensure compliance with all required study trainings.
EDUCATION CERTIFICATION LICENSURE REGISTRATION:
1. Bachelors degree in a scientific discipline or related field.
2. IATA Certificate- required within 30 days of hire
3. ICH GCP Certificate- required within 30 days of hire
4. CITI Training- required within 30 days of hire
EXPERIENCE KNOWLEDGE SKILLS and ABILITIES:
1. Must have excellent computer skills
2. Excellent written and verbal communication skills
3. Ability to work as a part of a team
4. Medical Terminology
5. Analytical mindset to collect and interpret data
6. Outstanding organizational skills
7. Ability to work independently
8. Proficiency in data management
9. Strong time management skills
REASONING ABILITY:
1. Ability to solve practical problems and deal with a variety of concrete variables in situations
where only limited standardization exists.
2. Ability to interpret a variety of instructions furnished in written oral or schedule form.
INTERPERSONAL SKILLS:
1. Must interact and communicate both verbally and in written form.
2. Must interact and exchange information regarding patients with physicians and other
departmental personnel and outside agencies on a frequent basis while respecting the
confidentiality of patient information.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to
successfully perform the essential functions of this job.
1. While performing the duties of this job the employee is regularly required to talk or hear.
2. The employee regularly is required to stand walk sit use hand to finger handle or feel objects
tools or controls; and reach with hands and arms.
3. Specific vision abilities required by this job include close vision and the ability to adjust focus.
WORK ENVIRONMENT:
The work environment described here is representative of those an employee encounters while
performing the essential functions of this job.
This position involves potential exposure to infectious diseases. Team members are offered appropriate
vaccinations and safety training.
COMMENTS:
This description is intended to describe the essential job functions the general supplemental functions
and the essential requirements for the performance of the job. It is not an exhaustive list of all duties
responsibilities and requirements of a person so classified. Other functions may be assigned and
management retains the right to add or change the duties at any time. Reasonable accommodations
may be made to enable individuals with disabilities to perform the essential functions of the job.
This position is a Safety Sensitive Position. The essential functions physical demands and mental
competencies of this job require the employee to maintain the ability to work in a constant state of
alertness in a safe manner.