Clinical Research - Owosso, United States - Memorial Healthcare

Description

JOB SUMMARY Reporting to the Clinical Research Manager, the Clinical Research Intern (CRI) will help to coordinate and/or implement his or her assigned duties.

In this role, the CRI will assist in the development of an electronic database using REDCap Cloud platform. The CRI may also evaluate and abstract research data while ensuring compliance with research and clinical trial protocol objectives.

The CRI may be responsible for completing case report forms, entering data into research databases, and assisting with regulatory submissions to the Institutional Review Board (IRB).

The CRI may also have limited contact with research subjects as assigned by the Manager.

The CRI will be expected to comply with all federal and local agencies including the FDA and the IRB with oversight on the assigned clinical trials.

The Clinical Research Intern (CRI) position is perfect for an individual who is seeking research experience in anticipation of a higher degree in life sciences, particularly nursing (BSN), medical school (MD), physician assistant (PA) or Ph.

D.

The position would also be perfect for individuals who have experience in building research studies in a data management system or designing eCRFs.

The CRI will have day-to-day contact with top medical sub-specialists and researchers in the fields of neurology.

Strives for superior performance by consistently providing a product or service to leadership and staff that is recognized as ultimately contributing to the patient and family experience.# Recognizes and demonstrates understanding of patient and family centered care.# This position is for 35 hours a week for 10 weeks, with possibility of extension.

This internship is a paid position.
PRIMARY JOB RESPONSIBILITIES Assisting CRC, Research Nurse, or Manager of Clinical Research in study coordination and implementation. Evaluating and abstracting research data from source documents. Compliance with protocol and overall clinical research objectives. Completing Case Report Forms (CRFs). Data entry to Electronic Data Capture systems (EDCs). Supervised contact with research participants related to day-to-day subject management and/or longer-term follow-up. Biological sample preparation and shipping Maintenance of study supplies and kits. Reporting any concerns regarding data quality, data integrity, and study conduct. At all times, the CRI will ensure compliance with local and federal agencies such as the FDA and IRB. This includes maintaining all research conduct using Good Clinical Practice (GCP) guidelines. Additionally, the CRC will be expected to maintain strict patient confidentiality according to HIPAA regulations and applicable laws.

Demonstrates knowledge of and supports hospital mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality statements, corporate compliance plan, customer service standards, and the code of ethical behavior.

DEPARTMENTAL AND ADDITIONAL JOB RESPONSIBILITIES 1. #The CRI may also be involved in other regulatory duties, budgeting duties, and assisting with reconciliation of study invoices. 2.

Other duties as assigned
JOB SPECIFICATIONS
EDUCATION Junior or senior college student working towards a BA/BS degree in the life sciences, computer science or similar analytically oriented field is strongly preferred.

EXPERIENCE Prior clinical research experience is preferred, but not required.

Prior experience with REDCap Cloud or EDC development preferred, but not required GCP Certification preferred, but not required IATA Certification preferred, but not required ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS These physical requirements are not exhaustive and additional job related physical requirements may be added on an as needed basis.

Corrective devices may be used to meet physical requirements. Able to travel independently throughout all Memorial Healthcare facilities. Small motor skills required for operating modern computer, office, and telephone equipment as utilized by Memorial Healthcare (MHC).


Sedentary Work:
Frequently required to stand, kneel and crouch. On a daily basis may be required to move about, sit, climb stairs and bend. Is frequently required to lift and carry up to 20 lbs. May be required to push/pull/carry items between lbs.


Vision:
Requires the ability to perceive the nature of objects by the eye


Near acuity:
Clarity of vision at 20 inches or less


Midrange Acuity:
Clarity of vision at distances of more than 20 inches and less than 20 feet


Motor Coordination:

While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms.

Must be able to travel independently throughout the hospital; access patients/families including areas confined by space and/or equipment.


Speaking/Hearing:
Ability to give and receive information through speaking and listening.
ESSENTIAL TECHNICAL ABILITIES Proficiency using modern office, computer and telephone equipment as used by Memorial Healthcare. Computer skills, including fluency in Microsoft Excel, PowerPoint, and Word are required. Biostatistical skills and knowledge of basic data management software are a plus.
ESSENTIAL MENTAL ABILITIES Ability to adapt and maintain focus in fast paced, quickly changing or stressful situations.

Ability to read and interpret a variety of documents including, but not limited to policies, operating instructions, white papers, regulations, rules and laws.

Analytical, Prioritization, and planning of work activities. Attention to detail and accurate documentation of research and office activities and adapts to changing conditions.

ESSENTIAL SENSORY REQUIREMENTS

Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.

Able to hear for work-related purposes.

Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.

INTERPERSONAL SKILLS Ability to interact with co-workers, hospital staff, administration, patients, physicians, the public and all internal and external customers in a professional and effective, courteous and tactful manner, at all times, physically, verbally and in all written and electronic communication.

Required to remain calm when adversity is encountered. Open, honest, and tactful communication skills. Ability to work as a team member in all activities. Positive, cooperative and motivated attitude.

Demonstrates knowledge and support of Memorial Healthcare mission, vision, value statements, standards, policies # procedures, confidentiality statements and corporate compliance plan.

JOB SUMMARY

Reporting to the Clinical Research Manager, the Clinical Research Intern (CRI) will help to coordinate and/or implement his or her assigned duties.

In this role, the CRI will assist in the development of an electronic database using REDCap Cloud platform. The CRI may also evaluate and abstract research data while ensuring compliance with research and clinical trial protocol objectives.

The CRI may be responsible for completing case report forms, entering data into research databases, and assisting with regulatory submissions to the Institutional Review Board (IRB).

The CRI may also have limited contact with research subjects as assigned by the Manager.

The CRI will be expected to comply with all federal and local agencies including the FDA and the IRB with oversight on the assigned clinical trials.

The Clinical Research Intern (CRI) position is perfect for an individual who is seeking research experience in anticipation of a higher degree in life sciences, particularly nursing (BSN), medical school (MD), physician assistant (PA) or Ph.

D.

The position would also be perfect for individuals who have experience in building research studies in a data management system or designing eCRFs.

The CRI will have day-to-day contact with top medical sub-specialists and researchers in the fields of neurology.

Strives for superior performance by consistently providing a product or service to leadership and staff that is recognized as ultimately contributing to the patient and family experience.

Recognizes and demonstrates understanding of patient and family centered care.

This position is for 35 hours a week for 10 weeks, with possibility of extension. This internship is a paid position.


PRIMARY JOB RESPONSIBILITIES

• Assisting CRC, Research Nurse, or Manager of Clinical Research in study coordination and implementation.
• Evaluating and abstracting research data from source documents.
• Compliance with protocol and overall clinical research objectives.
• Completing Case Report Forms (CRFs).
• Data entry to Electronic Data Capture systems (EDCs).
• Supervised contact with research participants related to day-to-day subject management and/or longer-term follow-up.
• Biological sample preparation and shipping
• Maintenance of study supplies and kits.
• Reporting any concerns regarding data quality, data integrity, and study conduct.
• At all times, the CRI will ensure compliance with local and federal agencies such as the FDA and IRB. This includes maintaining all research conduct using Good Clinical Practice (GCP) guidelines. Additionally, the CRC will be expected to maintain strict patient confidentiality according to HIPAA regulations and applicable laws.

• Demonstrates knowledge of and supports hospital mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality statements, corporate compliance plan, customer service standards, and the code of ethical behavior.

DEPARTMENTAL AND ADDITIONAL JOB RESPONSIBILITIES

• The CRI may also be involved in other regulatory duties, budgeting duties, and assisting with reconciliation of study invoices.
• Other duties as assigned

JOB SPECIFICATIONS

EDUCATION

• Junior or senior college student working towards a BA/BS degree in the life sciences, computer science or similar analytically oriented field is strongly preferred.

EXPERIENCE

• Prior clinical research experience is preferred, but not required.
• Prior experience with REDCap Cloud or EDC development preferred, but not required
• GCP Certification preferred, but not required
• IATA Certification preferred, but not required

ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS

These physical requirements are not exhaustive and additional job related physical requirements may be added on an as needed basis.

Corrective devices may be used to meet physical requirements.

• Able to travel independently throughout all Memorial Healthcare facilities.
• Small motor skills required for operating modern computer, office, and telephone equipment as utilized by Memorial Healthcare (MHC).

*Sedentary Work: Frequently required to stand, kneel and crouch. On a daily basis may be required to move about, sit, climb stairs and bend. Is frequently required to lift and carry up to 20 lbs. May be required to push/pull/carry items between lbs.
*Vision: Requires the ability to perceive the nature of objects by the eye


Near acuity:
Clarity of vision at 20 inches or less


Midrange Acuity:
Clarity of vision at distances of more than 20 inches and less than 20 feet.

• 
  Motor Coordination:

  While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms.

  Must be able to travel independently throughout the hospital; access patients/families including areas confined by space and/or equipment.

*Speaking/Hearing: Ability to give and receive information through speaking and listening.


ESSENTIAL TECHNICAL ABILITIES

• Proficiency using modern office, computer and telephone equipment as used by Memorial Healthcare.
• Computer skills, including fluency in Microsoft Excel, PowerPoint, and Word are required.
• Biostatistical skills and knowledge of basic data management software are a plus.

ESSENTIAL MENTAL ABILITIES

• Ability to adapt and maintain focus in fast paced, quickly changing or stressful situations.

• Ability to read and interpret a variety of documents including, but not limited to policies, operating instructions, white papers, regulations, rules and laws.

• Analytical, Prioritization, and planning of work activities.
• Attention to detail and accurate documentation of research and office activities and adapts to changing conditions.

ESSENTIAL SENSORY REQUIREMENTS

• Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.

• Able to hear for work-related purposes.

• Able to see for the purpose of reading information received in formats including but not limited to paper, computer, reports, bulletins, updates, manuals.

INTERPERSONAL SKILLS

• Ability to interact with co-workers, hospital staff, administration, patients, physicians, the public and all internal and external customers in a professional and effective, courteous and tactful manner, at all times, physically, verbally and in all written and electronic communication.
• Required to remain calm when adversity is encountered.
• Open, honest, and tactful communication skills.
• Ability to work as a team member in all activities.
• Positive, cooperative and motivated attitude.
• Demonstrates knowledge and support of Memorial Healthcare mission, vision, value statements, standards, policies & procedures, confidentiality statements and corporate compliance plan.