Notice
: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams.
This posting is not for a position directly at MCRA, but rather for a position with an MCRA client that our team is helping to recruit and fill.
MCRA’s client offers a robust orthopedic and sports medicine portfolio, including implants and high-strength fiber solutions, cordless LED surgical headlights, and a suite of brachytherapy products for the oncology market.
Position Overview
Our client is seeking a Contract Clinical Project Manager for a
part-time, 10-20 hours per week, 6-month assignment
. The Contract Clinical Project Manager will be responsible for the management of assigned investigator sites and overseeing site staff. Clinical affairs duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
Responsibilities and Duties:
- Coordinate and manage all phases of clinical trials from start-up to close-out.
- Ensure project deliverables are met within scope, timeline, and budget.
- Develop and maintain positive relationships both internally and externally, including clients, team members, and site personnel (PIs, Study coordinators, etc.).
- Maintain clear and consistent communication with surgeons, site staff, and internal teams.
- Manage retrospective patient data collection projects.
- Exhibit great customer service skills and work effectively with minimal oversight/training.
- Maintain current knowledge of GCP and FDA guidance as it relates to clinical research.
- Work independently and proactively.
Required Qualifications:
- Bachelor's degree (B.A./B.S.) in life sciences, healthcare, or a related scientific discipline, or be a Registered Nurse/Allied Health Professional with clinical research experience.
- Clinical Research certification preferred but not required.
- 2+ years of direct, on-site clinical trial monitoring experience required.
- Medical device experience required; vascular experience is highly desirable.
- Strong knowledge of ICH guidelines for GCP.
- Experience using Electronic Data Capture (EDC) and clinical trial management systems (Smart Trial preferred but not required).
- Strong written and verbal communication and presentation skills.
- Strong research, analytical, critical-thinking, and problem-solving skills.
- Proficiency with MS Office Suite (Outlook, Word, PowerPoint, Excel) and internet applications.
Special Requirements:
- Occasional travel may be required for site visits and/or meetings.
- Home-based, EST time zone preferred.
Note
: This job description is not intended to be all-inclusive. The employee may perform other related duties as needed to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
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