Research Assistant

Job Description

Job Description

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! 

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. 

About the Job:

We are actively hiring a Research Assistant to support our Detroit, Michigan site.

PURPOSE: The Research Assistant I is an essential team member in the conduct and execution of clinical research studies. The Research Assistant is to assist under direct supervision of the Site Director or Clinical Research Coordinator (CRC) in clinic supporting activities and perform duties and procedures related to the start-up, conduct and close-out phases of clinical research protocols. Under direct supervision and direction, to help obtain clean, objective, and accurate data within provided timelines while following applicable federal regulations, medical ethics, Good Clinical Practices (GCPs), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. All responsibilities should be completed in accordance with Flourish Research’s Mission Statement and Employee Manual.

ESSENTIAL RESPONSIBILITIES

A.    Read and understand protocols to help accomplish protocol specified patient visits and procedures as directed by assigned Team Lead or CRC.

B.    Under the direction of assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs.

C.    Obtain patient informed consent according to federal regulations, GCPs and IRB requirements.

D.    Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB and GCP guidelines.

E.     Assist in the scheduling and conducting of patient visits according to protocol requirements and timelines as directed by assigned Team Lead or CRC.

F.     Under close supervision, maintain accurate and complete written source documentation of patient visits and protocol related activities.

G.    Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor or CRO.

H.    Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements including but not limited to those with Flourish Research, between Flourish Research and sponsors, and between Flourish Research and other entities.

I.      Promptly report adverse events to the Team Lead , CRC, or other supervisors and/or Principal Investigator/Sub-Investigator as deemed necessary.

J.      Assist in the accountability of clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate quantities required for the conduct of the study.

K.    Maintain ongoing communication with Team Lead , CRC’s , Site Director , Principal Investigator, and other people assisting with the study and document these communications according to protocol requirements as well as Flourish Research policies.

L.     Attend training courses/conferences required to remain current and aware of changing federal regulations and Flourish Research policies.

M.   Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.

N.    Perform all study-related duties in a time- and cost-effective manner in adherence with Flourish policies.

O.    Perform all duties in a safe and prudent manner.

P.     Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with Flourish staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician’s offices.

Q.    Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS

A.    Work is normally performed in a typical interior/office work environment.

B.    Local travel may be required.

C.    Exposure to human bodily fluids.

D.    Laboratory processing procedures.

E.     Participant care.

F.     Extensive computer use.

G.    The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

H.    Occasional night and weekend work schedules.

I.    The ability to drive and daily availability of an automobile.

Requirements

MINIMUM REQUIREMENTS:

Education: Associate in science degree or commensurate experience within the field of clinical research. Bachelor's degree preferred.

Experience: Preferably a minimum of 1-3+ years’ experience within the field of clinical research or biological research.

Knowledge and Skills:

A.    Exceptional knowledge of clinical research methods.

B.    Demonstrates core values & all skills set required.

C.    Demonstrated ability to collaborate and align with all research department teams.

D.    Excellent oral and written communication skills.

E.     Excellent computer skills to include Office365 products.

F.     Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics, and other employees.

G.    Must be professional, have a strong work ethic, be motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments.

H.    ECG, phlebotomy skills, and any other technical skills related to the completion of a study visit as required by the protocol.

I.     Must have the ability to adapt and take on additional tasks as requested.

J.    Assists with key initiatives/process improvements in the department.

K.   Assists with training company new hires.

L.    Completes at least 80% of goals annually.

Benefits

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays. 

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.