Sub-Investigator

Job Description

Job Description

Valkyrie Clinical Trials (VCT) , a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado.

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!

We are actively hiring a Sub-Investigator to support our Valkyrie Clinical Trials Denver, Colorado site.

LOCATION : Onsite
FLSA : Exempt
HOURS : Monday to Friday, Day Shift, 40 hours per week
COMPENSATION : $130,000 to $150,000 per year (depending on experience)

ESSENTIAL JOB FUNCTIONS:

• Represent Flourish Research in a professional and courteous manner (verbal, written, and in appearance) during all interactions with sponsors, physicians, physicians' office personnel, participants, Flourish Research employees, contract personnel, as well as any other person(s) when carrying out tasks and responsibilities.

• Ensure the maintenance of confidentiality of participant information by team members as appropriate and as bound by Confidentiality Agreements with Flourish Research, between Flourish Research and sponsors/CROs, and between Flourish Research and other entities while abiding by HIPAA regulations.

• Assume overall responsibility for the success of Flourish Research under the direction of, as applicable, the CEO, General Manager, Site Director, and Medical Director.

• Possess a thorough knowledge and understanding of the requirements of each study protocol.

• Determine whether inclusion/exclusion criteria are applicable to the study population.

• Follow each study's randomization procedures.

• Maintain protocol compliance, including implementing only protocol deviations or changes approved by the sponsor/CRO and IRB (except to eliminate immediate hazards to the participant).

• Review the inclusion/exclusion criteria, procedures, scheduled visits, end point criteria, and investigational product use with the research team.

• Ensure that a qualified physician is responsible for all trial-related medical decisions.

• Assess participant compliance with protocol requirements and follow-up visits. Assess participant response to therapy. Evaluate adverse experiences and determine severity and relationship to the investigational product.

• Ensure that medical care is provided to a participant for any adverse event(s).

• Document and report all serious adverse events immediately, and within 24hrs of becoming aware of the event to the sponsor/CRO and IRB.

• Obtain signed and dated informed consent from the study participant or participant's legal representative prior to initiating any study-related procedures.

• Inform the participant or legal representative about all aspects of the clinical trial.

• Document that informed consent has been obtained from the participant or legal representative.

• Always consider participant safety and welfare the priority.

• Ensure the accuracy, completeness, legibility, and timeliness of case report forms (CRFs).

• Explain any discrepancies between source documents and case report forms (CRFs).

• Endorse changes or corrections to a case report form (CRF).

• Review and sign data management queries and case report forms (CRFs) in a timely manner.

• Document deviations from the approved protocol.

• Document and explain premature unblinding of the investigational product(s).

• Conduct, when necessary, clinical interviews and administer a variety of psychological tests, clinical rating scales, and/or diagnostic assessments.

• Evaluate results through scoring and documented findings in participants’ medical records and Flourish Research CTMS, eDocs, Source/EMR.

• Ensure validity and reliability when administering tests/scales/assessments by complying with established standards for administering all testing and per sponsors’ protocols.

• Ascertain and document the reason for a participant’s premature study withdrawal.

• Comply with written procedures to document changes to data and/or case report forms (CRFs).

• Read the current investigator’s brochure, product insert, or other source information.

• Develop thorough knowledge and familiarity with the use of the investigational product(s).

• Collaborate closely with pharmacy, nursing, administration, and all study personnel to ensure excellence in study conduct and patient care.

• Attend Investigator meetings, SIVs, monitoring visits, and industry conferences as needed.

• Perform other administration duties as needed or directed by, as appropriate, the General Manager, Site Director, or Medical Director.

Requirements

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

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

• Exposure to human bodily fluids;

• Laboratory procedures to obtain specimens and processing of specimens;

• Participant/Patient Care;

• Daily computer use;

• Local travel required to ensure coverage at all sites, if multiple local locations;

• Occasional travel for meetings and conferences;

• Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

MINIMUM REQUIREMENTS:

Education: Medical (M.D.) degree, Doctor of Osteopathy (D.O.), Doctor of Nursing Practice (D.N.P.), Physician’s Assistant (P.A.), Advanced Practice Nurse Practitioner (APRN), Doctor of Psychology (PsyD).

Experience: A minimum of 2 years’ experience in performing physicals, assessing, and treating patients. 1-3+ years' experience within the field of oncology clinical research; early phase oncology clinical trial experience preferred.

Knowledge and Skills:

• Strong supervision, interpersonal, and communication skills.

• Able to make good, sound decisions under stressful situations and time constraints.

• Must be able to make sound medical judgments on the health and safety of subjects during their participation in a clinical research study.

• Maintain professional and technical knowledge by attending educational workshops in other activities to maintain continuing medical education requirements.

• Review professional publications.

• Must possess exceptional organizational and planning skills and good documentation skills.

• Must have good conflict resolution skills and be committed to quality and honesty.

• In-depth knowledge of the clinical research process, including Good Clinical Practices.

Benefits

Flourish Research offers an excellent comprehensive benefits package to include: 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.