Lead Project Manager

K2 Staffing LLC•Maitland, FL

5h•Onsite

About The Position

At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most. K2 is seeking an experienced Lead Clinical Research Coordinator/Project Manager to support our clinic out of Orlando (Maitland), FL. This position will supervise a team of Project Managers; assist the Site Director with day-to day operations; and provide leadership and support to clinical staff to ensure high quality/high volume of work, efficient productivity, and maintain effective + positive working relationships with patients, sponsors, physicians, and employees.

Requirements

Outstanding verbal and written communication skills
Excellent interpersonal and customer services skills
Strong time management and organizational skills
In depth knowledge of industry regulations
Proven ability to foster mentoring relationships
Ability to create momentum and foster organizational change
Bilingual in Spanish/English highly desired.
HS Diploma or GED Transcript required. Bachelor's degree strongly preferred.
At least two (2) full years of Clinical Research Coordinator or Project Manager experience required.
Prior experience in a clinical environment preferred.
Experience in clinical research and Parkinson's (neurodegenerative disease) is ideal.
Phlebotomy, LPN, RN, or other medical licensure or certification preferred.
CCRC certification preferred.
Strong working knowledge of GCP and FDA guidelines.
Knowledge of medical terminology.
BLS Healthcare Provider desired.

Nice To Haves

Bilingual in Spanish/English highly desired.
Bachelor's degree strongly preferred.
Prior experience in a clinical environment preferred.
Experience in clinical research and Parkinson's (neurodegenerative disease) is ideal.
Phlebotomy, LPN, RN, or other medical licensure or certification preferred.
CCRC certification preferred.
BLS Healthcare Provider desired.

Responsibilities

Train new and current Project Managers and Clinical Research Assistants to ensure effective coordination of training activities in the clinical trials processes
Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator
Adhere strictly to the study protocol; obtain exemptions when necessary/appropriate
Communicate protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator
Articulate all pertinent issues to the Pl or document by email/letter or during meetings
Collect initial psychiatric and medical information by interviewing patients and by accessing other appropriate sources
Ensure a flow of communication including telephone conferences between patient, study staff, referral sources, Sponsor and/or CRO, Monitor(s), Auditors and any marketing groups hired by the Sponsor
Utilize various psychiatric rating scales and maintaining interrater reliability with other clinicians at K2 Medical Research
Perform clinical tasks including, but not limited to, vital signs, height and weight, ECG, phlebotomy, specimen packaging
Maintain timely K2 Medical Research source documentation as well as sponsor required information.
Dispense and maintain accurate records of study medication
Educate patients and family regarding their particular study and clinical drug trials in general.
Complete all monitor and sponsor queries in a timely manner
Provide appropriate community resource referrals to patients, caretakers, and family at conclusion of patient's participation in study