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Clinical Research Assistant

SUMMARY: Assists in coordinating the conduct of clinical research protocols/projects with an emphasis on the screening, enrolling, and monitoring of patient candidates/participants.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Job Duties and Responsibilities

Independently comprehend complex clinical research protocols, with careful attention and strict adherence to detail. Can implement protocols when needed.

Assist and manage local IRB (if applicable)

Can assistant and help Manage multiple oncology studies, both observational and interventional

Exercise integrity and discretion in all matters and protecting confidential information and/or protected health information as dictated by assignment, policy or regulation.

Demonstrate advanced level skills preparing correspondence and recruitment materials.

Assists in the informed consent process including preparation discussions with research participants or answering any questions related to the study.

Obtain appropriate signatures and dates on forms in appropriate places.

Prescreen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.

Coordinate participant tests and procedures.

Maintain adequate inventory of study supplies. If handling investigational drugs, follow the sponsor protocol and/or site SOP.

Thorough knowledge and understanding of "Good Clinical Practices" for clinical research.

Comprehend and understand GCP training. Keep all CRC Assistant training up to date and active while employed.

Participate in weekly huddle calls for the clinical trial department to effectively interpret and accurately compile data according to study protocol.

Knowledge of basic medical terminology, including oncology, and procedures

Independently organize tasks and set priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity.

Complete study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

Demonstrate advanced level computer skills for word-processing programs, database programs, and data management for Electronic Data Capture (EDC) portals.

Assist the PI and Research Manager in study feasibility assessments as requested.

Coordinate with Principal Investigator, Exigent administration, and site staff to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.

Assist Principal Investigator and CRC(s) to assure that all key personnel or persons engaged in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures.

Provides appropriate training and tools for study team members.

Documents date of training and signatures of study personnel trained on study specific training log.

Coordinate and facilitate monitoring visits with Sponsor organizations

Participate in internal/external research related conferences and investigator meetings to build and maintain relationships

Velos/Payment Data entry

Work with and understand Exigent Network Operations and their platforms

Update information in Florence ebinders

Complete understanding of Microsoft Word and Excel

Can fully manage and update google drive forms, sheets, and clinical trial documents

Any other duty asked upon you by the research manager, administrative team or shareholders.

Professional Communication
- Maintains confidentiality in matters relating to all aspects of employment, including patient/family/significant other confidentiality.
- Interacts with patients/family/significant others with a variety of developmental and sociocultural backgrounds in appropriate manner.
- Provides information to patients and family/significant others that reduces anxiety and conveys an attitude of acceptance, sensitivity and caring.
- Maintains professional relationships and conveys relevant information to other members of the health care team.
  - Internal Contacts: Physicians, nurse practitioners, other RNs, LPNs, Medical Assistants, laboratory staff, pharmacy staff, secretaries, scheduling, billing representatives, etc., and staff at other CCSI facilities.
  - External Contacts: Research, home health care, hospice, blood banks, hospitals, same day surgery, x-ray departments, couriers, pharmacies, laboratories, floor nurses, other provider offices, etc.
- Communicates and coordinates with other healthcare professionals to obtain and follow through on provider orders, such as blood orders, occupational therapy, physical therapy, medical equipment, etc.; Hospice consults; case management, such as pre-certifications for drugs or tests; and, provider referrals.
- Relays information appropriately over computers, telephones, facsimiles, pagers, and other communication devices, and follows-through as needed.
- Maintains and prioritizes messages, gathers appropriate information needed to respond (such as patient chart, lab results, etc.), communicates appropriate information to providers, and follows-through on provider orders and requests as needed. In provider’s absence, checks and assesses provider messages regularly and addresses as needed.
- Initiates / coordinates with insurance companies to obtain pre-certifications and pre-authorizations for patients’ medications and procedures.
- Will be proficient on the electronic medical records system and accurately and completely document patient information utilizing the system.

Teamwork
- Works collaboratively as a health care team member.
- Reports on patient conditions as needed to those who require information, including providers, supervisors, and other professional staff as appropriate while maintaining patient confidentiality.
- Assists with tasks necessary for the general operation and organization of the Nursing unit.
- Maintains positive attitude with patients, family/significant others and coworkers.

Professional Development
- Attends staff meetings and mandatory in-services.
- Participates in continuing education opportunities and maintains licensure.
- Maintains necessary certification(s) and licensure(s).
- Contributes to the quality of patient care and participates in quality improvement initiatives.

OTHER DUTIES: Performs other duties as assigned.

EDUCATION/QUALIFICATIONS:

Licensure, Registration, and/or Certification Required:

None Required.

Education Required:
- High school diploma (required)
- Bachelor’s Degree or MA/LPN
- Prior experience in Oncology (preferred)
- Basic CPR certified (preferred/ not required)
- One year experience in a medical or research field (preferred)
- Phlebotomy experience/license (preferred/ not required)
- Working knowledge of all Microsoft office computer programs.
- Working knowledge of EMR system

Experience Required:

Typically requires 1 years of experience in Research.

Knowledge, Skills & Abilities Required:

Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures.

Ability to successfully conduct and manage a research study.

Ability to mentor team members and to prepare training plans. Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree of accuracy and attention to detail.

Must be able to establish a good rapport with patients, investigators and sponsors.

Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs

Physical Requirements and Working Conditions:

Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift.

Must have functional sight and hearing.

Ability to function in a latex environment. May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.

Exposed to a normal office environment.

Operates all equipment necessary to perform the job.

Position may require travel among sites and therefore there is exposure to road and weather conditions.

G. Benefits

Health insurance

HSA Option

Dental insurance

Paid Time Off (PTO)

Sick Time

Vision insurance

401(K) 1/ match & profit sharing

Life Insurance

Short- & Long-Term Disability

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties

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