Subinvestigator

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Job Purpose: Conduct clinical studies according to study protocols, review safety data and monitor the safety of study participants enrolled into clinical trial protocols under the supervision of the Principal Investigator.  Essential Functions

Maintain timely compliance with Celerion’s SOPs, required study documents, and other study- specific mandatory trainings

Assist with training of new staff upon achieving personal proficiency in required skills and tasks.

Create a friendly and welcoming environment to study participants

Produce accurate and timely study data while ensuring participant safety

Participate in the ICF process by answering any volunteer questions about the study, in collaboration with the investigator as needed.

Conduct screening physical examinations

Review subject screening data, including subject medical histories, ECGs, laboratory studies, and any other ancillary tests as outlined by the study protocol.

Make preliminary eligibility decisions based on protocol inclusion and exclusion criteria.

Counsel participants regarding abnormal tests and make referrals in collaboration with the investigator as necessary

Attend Sponsor SIVs

Assist in the logistical setup of new studies by collaborating with the nursing department and working with study management to ensure the successful execution of all medical aspects of the protocol

Provide training to clinic associates as needed

Resolve queries During study

Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner

Conduct physical examinations

Perform minor procedures as outlined by the protocol following completion of required training

Engage with client in-person (on-site) or via written, electronic or telephone correspondence to address any medical-related issues

Ensure safety of study participants by reviewing and managing adverse events and serious adverse events under the supervision of the PI. Perform assessments and administer necessary treatment when required

Assist in referring participants to specialists as necessary

Review of outside medical records if requested by the investigator

Review of SUSAR reports if requested by the investigator

Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner

Conduct physical examinations

Resolve queries

A flexible schedule that could include Friday - Monday (start times may vary between 7am and 8am) for a minimum 10 hours a week

Knowledge/Skills/Education/Licenses

Excellent oral and written communication skills

Proven organizational skills, ability to multi-task and manage multiple priorities

Demonstrates attention to detail

Strong customer service and interpersonal skills

Team player with the ability to work collaboratively

Willingness and ability to work flexible hours including weekends and holidays to ensure clinic coverage

Nurse Practitioner, Physician Assistant, or MD/DO

Eligible to obtain DEA certificate upon hire.

Training in Basic Life Support and Advance Cardiac Life Support, or willing to obtain upon hire

Board certified or board eligible in a primary care specialty, i.e. family practice, internal medicine, E.R. medicine or as a PA-C or NP, or MD/DO

1 year medical experience and / or clinical research experience

Spanish language skills a plus