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Oak HC/FT

Site Development Coordinator (Hybrid-Travel)

Profound Research

Profound Research

Remote
Posted on Thursday, July 11, 2024
The Company
Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available.
Mission, Vision, Values
o Mission: Ensure that every patient has access to innovative treatments and improve patient lives.
o Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.
o Values:
o Compassion: Honor the patient-physician relationship above all else.
o Efficiency: Accountable for outcomes and strive for process perfection.
o Progress: Contribute to continued innovation in medicine while improving health outcomes.
o Integrity: Hold ourselves to the highest ethical, quality, and scientific standards in every activity
Profound Ethos
Physicians are the Vanguard
All Decisions Improve Patient Care
Never Compromise Quality
Why this Role Exists
The Site Development Coordinator floats to support both newly identified Profound Research sites and established Profound Research sites to execute the clinical trials effectively, efficiently, and in accordance with International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines, FDA regulations, and sponsor protocol. This role may require up to 75% travel.
Responsibilities
Full time role with regular travel to local and interstate sites.
Works with Profound Research facilities to ensure site equipment requirements are in place.
Assists with training and onboarding (where appropriate) of new study staff (such as site management and study coordinators) at
sites.
Assists with new investigator and site/practice staff training.
Provides site infrastructure setup expertise to ensure new Profound Research sites are ready to conduct clinical trials as soon as possible after identification.
Acts in a Clinical Research Coordinator (CRC) role for new and/or existing sites which includes overseeing clinical trials, enrolling and retaining participants in trials, completion of data entry, query resolution, and management of trial communication.
Assists with the interviews for new site management and study coordination staff.
Facilitates pre-study, site qualification, study initiation, monitoring visits, and study close-out activities for sites as needed.
Partners with General Manager and Clinical Research Coordinators (CRC) for site activation and readiness.
Provides oversight of new site staff hires for up to 6 months to ensure they are competent in
their role.
Requirements
2+ years of clinical research coordinating experience.
BA/BS in Life Science or related field preferred.
CCRC/CCRP certification a plus.
Phlebotomy experience a plus.
Knowledge of medical terminology.
Must have previous experience of EDC entry and query resolution.
Strong interpersonal skills with strong verbal and written skills.
Demonstrated ability to keep projects on time to meet business outcomes.
Proficiency with utilizing computers and technology, including but not limited to MS Office 365 applications and other research specific platforms.
Ability to travel up to 75% of the year.
A willingness to pivot quickly and adapt to changing business conditions.
Perform other duties as assigned.
Embrace Profound Research’s mission and ethos.
Other duties as assigned
Travel Requirements
Ability to travel up to 75% of the year is required in this position.
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer, standing and walking.
Must be able to lift 25 pounds at times.
Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Physical Requirements
· Prolonged periods of sitting at a desk and working on a computer, standing and walking.
· Must be able to lift 25 pounds at times.
· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.