Job Description

Job Description

Job Description

Description:

Work location : Clinical Trials Office 130 Town Center Drive, Suite 101, Troy, Michigan 48084

GENERAL SUMMARY

The Clinical Research Assistant will play a crucial role in supporting clinical research activities aimed at enhancing medical treatments and therapies. You will work closely with our team of study coordinators and medical professionals to ensure the smooth execution of clinical trials and studies.

ESSENTIAL JOB FUNCTION/COMPETENCIES

Responsibilities include but are not limited to:

• Responsible for Study Specific Training which includes initial study start-up information/ requirements, dissemination of updated Investigator’s Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study.
• Collects patient vital signs including height, weight, blood pressure, respirations, pulse temperature, O2 saturation.
• Source Document Completion which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly.
• Concomitant Medication Assessment by obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication.
• Responsible for Biological Sampling Collection/Packaging/Shipping this includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements.
• Case Report Form (CRF) Entries and Management data entry, query resolution in paper and/or electronic CRFs.
• Investigational Product (IP) Management – includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP.
• Develop and/or Maintain Essential Documents including study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms.
• Supply Chain Maintenance including supplies inventoried, stocking, organizing, and resupply order placed as required.
• Responsible for study coordination, rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits.
• Obtain/Maintain all required training- GCP, IATA,CPR and occasionally help the study coordinators at other offices.
• Performs other position related duties as assigned.
• Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• N/A

KNOWLEDGE | SKILLS | ABILITIES

• Ability to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work.
• Proficiency skills with Microsoft Word and Excel.
• Excellent computer skills.
• Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff.

EDUCATION REQUIREMENTS

• High School Diploma or equivalent required.
• Associate's degree or higher in a related field (biology, psychology, nursing or healthcare) preferred.

EXPERIENCE REQUIREMENTS

• Previous healthcare experience strongly preferred.
• Previous Research Assistant experience preferred.

REQUIRED TRAVEL

• Minimal travel required.

PHYSICAL DEMANDS

Carrying Weight Frequency

1-25 lbs. Frequent from 34% to 66%

26-50 lbs. Occasionally from 2% to 33%

Pushing/Pulling Frequency

1-25 lbs. Seldom, up to 2%

100 + lbs. Seldom, up to 2%

Lifting - Height, Weight Frequency

Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%

Floor to Chest, 26-50 lbs. Seldom: up to 2%

Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%

Floor to Waist, 26-50 lbs. Seldom: up to 2%

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